The ICMA Information Package on Medical Abortion
Information for health care providers
An estimated 19 million women globally have an unsafe abortion each year, resulting in 68,000 deaths, largely among the poorest and most vulnerable women, especially young women. Many more suffer injury and complications  and an estimated 5 million women per year are hospitalized for complications of unsafe abortion . Almost all these deaths and injuries are entirely preventable or treatable.
Unsafe abortion was recognized as a major public health issue at the International Conference on Population and Development (ICPD) in Cairo in 1994. Its Programme of Action called for:
Health professionals have played a significant role in promoting women’s access to safe abortion in many parts of the world. Individual health professionals in many countries have spoken out courageously on the need to prevent maternal deaths from unsafe abortions and have provided leadership in providing safe abortion services. Statements issued by many national and international organizations affirm the responsibility of health professionals in the provision of abortion services. For example, the Ethical Guidelines regarding induced abortion for non-medical reasons issued by the International Federation of Gynecologists and Obstetricians (FIGO) note that:
“ .. after appropriate counseling, a woman has the right to have access to medical or surgical induced abortion, the health services have an obligation to provide such services as safely as possible.” 
Medical abortion, the termination of pregnancy through the use of a drug or a combination of drugs, has revolutionized abortion procedures, because it is not dependent on surgical intervention. Medical abortion means that women can now have a choice between abortion methods, including women who are prevented by the lack of health service facilities from having a safe abortion. Because it is a simple procedure, it has the potential to expand access to abortion provided by clinicians and mid-level providers who may or may not have training in surgical methods of abortion. It also enables women in early pregnancy to take the medication(s) and have their abortion at home if they prefer to do so, as long as they have access to appropriate back-up medical services.
Mifepristone is now available in more than 35 countries and the list is growing. By 2004, more than 22 million women in China and about four million in the rest of the world had used medical abortion to terminate a pregnancy safely and effectively . In dozens more countries, misoprostol alone is also being used for safe and effective pregnancy termination.
In 2005, WHO added mifepristone and misoprostol to its complementary List of Essential Medicines for countries where abortion is not against the law. The List of Essential Medicines contains those medicines which are considered to satisfy the priority health needs of the population of developing countries, and which have been selected on the basis of their efficacy, safety and cost-effectiveness .
Provider knowledge and acceptance are important keys to expanding access to medical abortion services in all countries. Experience in Europe shows that providers who favour medical abortion get a much larger proportion of women opting for medical abortion, while providers whose attitudes are unfavourable tend to have fewer patients who choose the method . Although some potential providers have expressed concerns, the provision of medical abortion is not complicated – even in the second trimester – and does not require extensive training or high-technology back-up facilities . However, it does require that patients have access to appropriate medical/surgical back-up services when they are needed.
Lack of adequate information on medical abortion may also influence providers’ willingness to offer the method. In settings where abortion is legally restricted or where information has been scarce, providers may have administered incorrect dosages, resulting in unnecessary side effects or incomplete or failed abortions, which in turn may discourage them from continuing to provide the method .
This Information Package aims to help to bridge the information gap on medical abortion among health providers. This chapter is presented in six sections. The first section provides basic information on dosages and regimens, medical eligibility and screening protocols. The second section focuses on basic requirements in a health facility for providing medical abortion services or for back-up services when medical abortion is provided in non-clinical settings. The third section is on information provision and counselling, which are an important component of all abortion services. The fourth section is about training for providing medical abortion. The fifth section discusses promoting access to medical abortion in health systems. The last section summarizes what is happening in settings where although abortion is legally restricted, medical abortion is also being used extensively.
This chapter of the ICMA Information Package has borrowed extensively from the document entitled "Frequently Asked Clinical Questions about Medical Abortion" published in 2006 by the World Health Organization Department of Reproductive Health and Research. This document represents the conclusions of an international consensus conference on medical abortion in the early first trimester of pregnancy, which was attended by an international group of highly experienced researchers and clinicians in the field of medical abortion. The participants reviewed systematic reviews of available evidence concerning key issues related to the provision of medical abortion, in addition to their own experience, to reach consensus on answers to frequently asked questions that had been submitted by health care providers from around the world and made recommendations regarding clinical practice .
|2. Medical abortion: technical issues|
1. Drugs used for medical abortion
Combination of two drugs
The most commonly used combination of drugs for medical abortion is
Mifepristone blocks the action of progesterone in the body. This results in the withdrawal of progesterone support to the endometrium (decidua), enhanced contractility and the detachment of the implanted embryo. In addition, it causes marked softening and dilation of the cervix. Strong contractions of the uterus after misoprostol administration lead to expulsion of the products of conception. The process is very much like a spontaneous abortion or miscarriage.
Methotrexate and misoprostol
In some countries where mifepristone is not available, methotrexate is being used in combination with misoprostol. However, methotrexate is not recommended by the World Health Organization (WHO) for inducing abortion, because it causes fetal malformations if the pregnancy continues . The combination of methotrexate with misoprostol is less effective than the combination of mifepristone with misoprostol, and it involves a more prolonged and unpredictable abortion process. When mifepristone has become available, providers have typically switched to using it and stopped using methotrexate. Also, it is questionable whether the use of methotrexate gives any advantage over misoprostol-alone regimens.
2. Indications and usage
2.1 Indications and usage: misoprostol alone
It is possible to induce abortion in early pregnancy using misoprostol alone, for example in settings where mifepristone is unaffordable or not available. However, without mifepristone, a higher total dose of misoprostol, often with repeat doses of 800 micrograms, is needed, and it is less effective than regimens combining it with mifepristone. In addition, the abortion process can be more painful and have more side effects, including nausea, vomiting, abdominal pain, fever and shivering, with the incidence depending on the route of administration.There is also a higher rate of failed abortion and continuing live pregnancy.
The evidence until now suggests that when misoprostol is used alone to induce early abortion (up to 63 days) 2-3 doses of 800 micrograms of misoprostol are needed. The efficacy is higher when the intervals between doses are shorter, especially when the drug is administered sub-lingually (under the tongue) . Although the efficacy of vaginal administration is less sensitive to administration intervals, the data from pharmacokinetic studies  as well as from a randomized trial suggest that the optimal interval for vaginal administration is 3-6 hours. When misoprostol is given sublingually, it has to be administered at 3-hour intervals to achieve a similar effectiveness as with vaginal administration .
2.2 Mifepristone-misoprostol regimens
Labelling information for mifepristone states that the drug is indicated for the medical termination of intrauterine pregnancy up to 49 days with oral administration of misoprostol, and up to 63 days with vaginal administration of a prostaglandin analogue . Mifepristone followed by repeated doses of a prostaglandin analogue (most commonly misoprostol) is also licensed and widely used for abortion for later pregnancies. Studies carried out in many different countries provide evidence of the safety of medical abortion up to 24 weeks of gestation , , , , , .
However, it should be noted that while the dose of mifepristone does not change, the dose of misoprostol does need to be modified for different stages of pregnancy. A higher total dose is often needed in late first trimester compared to early first trimester. During the second trimester, due to increased sensitivity of the uterine muscles to prostaglandins, it is wise to lower the doses to avoid hyperstimulation and the risk of uterine rupture when the duration of pregnancy is beyond 22 weeks, or in the case of a uterine scar such as from a previous caesarean section. The combined mifepristone–misoprostol regimen can thus be used throughout pregnancy provided that the dosage of misoprostol is adjusted , .
There are very few absolute contraindications to medical abortion. When using a combination of mifepristone and misoprostol they include:
Caution is required if the woman:
Regarding other characteristics of the woman:
Age is not a consideration with regard to use of medical abortion.
Anaemia need not be regarded as a contraindication. However, anaemia detected at the time of abortion should be treated. Average blood loss after medical abortion may be more than that in surgical abortion , and the incidence of heavy bleeding may be higher as well as the duration of bleeding .
Breastfeeding. It is likely that mifepristone passes into breastmilk, but no clinical effects have been reported. Small amounts of misoprostol also enter breastmilk soon after administration, but it is not known whether this could have any effect on the infant. As misoprostol levels decline rapidly, it has been recommended that misoprostol should be taken immediately after a feed .
Insulin-dependent diabetes or thyroid disorder. There is no evidence that medical abortion causes any particular problems in women with these disorders.
Multiple pregnancy (current gestation). There is no evidence that the failure rate of medical abortion is increased or that a different dosage regimen is required in the case of multiple pregnancy.
Obesity. There is no evidence that the failure rate of medical abortion is increased or that a different dosage regimen is required in obese women.
Previous caesarean section. There is evidence from one study that the safety and efficacy of early medical abortion are unaffected by previous caesarean section .
Smoking. There is no evidence of interaction between the risks of smoking and medical abortion.
Uterine malformations, congenital and acquired; previous cervical surgery. There is no evidence that these represent contraindications; rather, medical abortion may be preferred with these conditions due to the increased difficulty of surgical procedures.
Caution is also required in the following situations:
IUD in sit.u. If a woman has an intrauterine device (IUD) in place, this should be removed prior to use of medical abortion.
HIV positive women. No studies to date have investigated the complication rates of induced abortion or the specific effects, if any, of unsafe abortion on women living with HIV. However, women with HIV may experience more complications than their HIV negative peers, as follows: HIV positive women are also at higher risk from anaemia, especially with malaria and with certain antiretrovirals, and may be less able to resist infections. HIV positive women may also be at higher risk of pelvic or vaginal infections from retained products of conception, which can occur with medical as well as surgical abortion. The small proportion of women who develop heavy bleeding with either method need to be treated promptly to avoid serious consequences. Research is needed on interactions between medical abortion drugs and antiretroviral drugs, as evidence is scarce .
Abortion is one of the safest medical procedures, but as with any medical procedure, there is always a small risk of complications. It is always important to remember that medical abortion is far safer than many of the dangerous methods of abortion women subject themselves to when safe abortion services are not available or accessible. Despite advances in abortion technology, procedure-related morbidity and mortality increase with gestational age. The experience with medical abortion until now suggests that it is safe when provided by trained health care professionals with adequate back-up services.
After medical abortion, the duration of bleeding is longer and the average blood loss may be more than in surgical abortion . Also, the incidence of heavy bleeding seems to be higher, and heavy bleeding (though affecting only a small proportion of women) is the most common adverse event in connection with medical abortion.
In general, bleeding is most abundant around the time of expulsion and some women will require treatment by uterotonic or vaso-constrictor drugs at that time. As heavy bleeding may also occur as late as 2-3 weeks after the treatment, emergency care and facilities for surgical intervention should be available locally or through a referral mechanism with established linkages. Back-up services should include uterine evacuation, fluid replacement and blood transfusion.
When women with pregnancies of up to 63 days LMP are treated with 200 mg of mifepristone followed 36–48 hours later by 800 micrograms of vaginal misoprostol, 95–98% of them have complete abortion, 2–4% have incomplete expulsion and 0.3% will require vacuum aspiration for continuing pregnancy , . The need for uterine evacuation for haemostatic purposes varies between studies from 0.35% to 2.5%, and is significantly higher among women at gestations of 49 days or more compared to earlier pregnancies (3.3% vs 1.5%; p=0.0193) . About two per thousand women treated required blood transfusion. Studies that have measured haemoglobin concentrations suggest a decrease, which is often significant, one to two weeks after treatment, but the values usually return to normal afterwards .
The most common problems reported at follow-up or unscheduled visits are continued pain and vaginal bleeding and discharge . Among women whose pregnancy was terminated, about half of those with an empty uterine cavity continued to bleed beyond 12 days, and >70% of those with missed abortion or debris found at ultrasound examination. According to a review , the overall frequency of diagnosed and/or treated infection reported after medical abortion was <1% (0.92%, n=46,421). Thus, infections after medical abortion seem to be rare, and possibly occur less often than after vacuum aspiration (See below 8. Management of side effects and complications).
Mifepristone and misoprostol act synergistically in combination. Used alone, both may lead to abortion but will have lower effectiveness (especially mifepristone alone). If misoprostol is used alone, higher doses are needed which leads to more side effects and pain. Following pre-treatment with mifepristone the total dose of misoprostol can be reduced, the efficacy increases and side effects will be lower. The only disadvantage of this sequential regimen is the cost of mifepristone. As cost considerations are important in many parts of the world, the challenge, therefore, has been to find a regimen combining the lowest doses of both drugs that are highly effective and have the fewest side effects.
In many countries, mifepristone is licensed for use as a single oral dose of 600 mg. However, there is no evidence that a dose of greater than 200 mg is necessary for optimal effect when followed by a suitable prostaglandin , , , . Therefore, the approved regimen (license) in
A 50 mg dose of mifepristone has been shown to be less effective than a 200 mg dose, when given in combination with the prostaglandin gemeprost vaginally . Studies are continuing to investigate the minimum effective dose of mifepristone.
The following regimens and dosages of drugs for medical abortion are based on the latest recommendations from the Royal College of Obstetricians and Gynaecologists and the World Health Organization.
The recommended regimen for medical abortion is 200 mg of mifepristone given orally, followed 24–48 hours later by 800 micrograms of misoprostol given vaginally , . This combination results in complete abortion in more than 96% of cases; the rate of continuing pregnancies is less than 1% in gestations up to 63 days’ amenorrhoea , , .
The misoprostol can also be given orally with a dose of 400 micrograms, but owing to the higher failure rate with this dose at higher gestational ages, it is recommended that use of oral misoprostol be restricted to very early pregnancy up to 49 days.
In some studies, repeated doses of misoprostol have been used, either routinely for all women or in those with evidence of incomplete abortion , , . Repeated doses are associated with an increased incidence of side-effects such as nausea, vomiting and shivering. There is some evidence that by repeating the administration of the prostaglandin, the efficacy increases somewhat when the gestational age is beyond 56 days, when the recommended regimen is used. However, when the interval between mifepristone and misoprostol is shorter than 24 hours or the gestational age is beyond 63 days, repeated misoprostol doses are often necessary to complete the abortion .
Lower vaginal doses and different routes of administration of misoprostol, e.g. buccal and sublingual, are currently under investigation and appear promising in the early first trimester.
Interval between administration of mifepristone and misoprostol
The licensed and most commonly used interval of 36–48 hours ,  corresponds to the time when the uterus is most sensitive to prostaglandin after priming with mifepristone; hence the therapeutic dose can be reduced to the minimum. This interval was also found to be the most effective in initial studies when uterine contractility was measured at different times between administration of mifepristone and of prostaglandin . It has been shown recently, however, that the interval can be shortened to 24 hours or lengthened to 72 hours, without loss of efficacy, when mifepristone is used in combination with 800 micrograms of vaginally administered misoprostol , . The 24-48 hour interval can also be used in second trimester abortion , , .
6. Pre-abortion management
Every woman with an unwanted pregnancy who is considering abortion should receive information about both medical and surgical methods of abortion in a way that she can understand, to allow her to make her own decisions about which method to choose. Most women have already made a decision before coming to the clinic. Nevertheless, some women require additional time and support in reaching a decision. Both counselling and the abortion should be provided without undue delay. Privacy is essential and women should be free to choose to be counselled alone or with a partner, parent, or friend.
Those providing abortion counselling must be familiar with their local legal framework regarding consent by young women below the legal age of consent. However, no woman should be coerced into involving her parents or partner when she is unwilling to do so.
Ideally, pre-abortion counselling should include discussion about future contraceptive needs. In helping a woman to choose the most appropriate contraceptive method for the future, it may be useful to explore the circumstances in which the unwanted pregnancy occurred. The goal of contraceptive counselling and provision in the context of abortion care is to begin the chosen method immediately after the abortion.
Confirmation of pregnancy and estimation of length of gestation
In most cases, pregnancy can be confirmed and its length estimated on the basis of the woman’s history and a physical examination. Occasionally, laboratory tests may be needed when the typical signs of pregnancy are not clearly present and the health care provider is unsure whether the woman is pregnant.
Ultrasound scanning is not necessary for the provision of early abortion. Where ultrasound equipment is available, a scan can help identify an intrauterine pregnancy and exclude ectopic pregnancy after about six weeks. It also helps to determine gestational age and diagnose pathologies or non-viability of a pregnancy.
Clinical assessment and laboratory investigations prior to medical abortion
As with any method of abortion, clinical history-taking should serve to identify contraindications and to identify risk factors for complications. History-taking should include: personal and family history of relevant diseases; current use of medications and known allergies; obstetric and gynaecological history, including ectopic pregnancies; any bleeding tendencies; and history of sexually transmitted infections (STIs). Social history should include a risk assessment for STIs, taking into account local STI prevalence rates. The clinician must be alert to the possibility of violence or coercion in the context of the unwanted pregnancy.
Basic routine observations (pulse, blood pressure, and temperature) are useful as a baseline.
There are no laboratory tests that are essential before medical abortion. However, tests such as haemoglobin level, blood group and rhesus (Rh) typing, and screening for hepatitis, human immunodeficiency virus (HIV), and STIs, may be offered on the basis of individual risk factors or available resources. Ideally, services should offer testing for pathogens in the lower genital tract, and treat women found positive.
The prevalence of Rh-negative status varies markedly with ethnicity, being highest among Caucasians. For pregnancies up to 63 days gestation, the theoretical risk of maternal Rh sensitization is very low; there is no evidence that sensitization occurs at this stage of pregnancy. Thus, determination of blood group and Rh status and the offer of anti-D prophylaxis to Rh-negative women are not considered prerequisites for early medical abortion. In settings where the prevalence of Rh-negative status is high, and where resources permit, the offer of Rh typing and anti-D prophylaxis could be worthwhile as precautionary components of medical abortion care.
Risk of undiagnosed ectopic pregnancy
Mifepristone and misoprostol are not treatments for ectopic pregnancy which, if present, will continue to grow. If medical abortion is contemplated very early in gestation, i.e. before an intrauterine pregnancy can be diagnosed with ultrasound, clinicians must be particularly alert to the possibility of ectopic pregnancy. They should check whether the uterus feels smaller than expected according to the date of the woman’s last menstrual period. Women should seek medical advice promptly if they experience symptoms and signs that may indicate ectopic pregnancy, such as abdominal pain on one side. Verification of expulsion in these very early cases can be done only by comparing human chorionic gonadotrophin (hCG) levels prior to the treatment and at follow-up
Where clinical features (e.g. history of ectopic pregnancy or STI, discrepancy between menstrual dates and ultrasound appearance, vaginal bleeding, or pelvic pain) raise suspicion of an ectopic pregnancy, appropriate tests should be done. If ectopic pregnancy is diagnosed or strongly suspected, the woman should be transferred to an appropriate gynaecology service for continuing care.
7. The abortion procedure
A single 200mg tablet of mifepristone is taken orally. Depending on the national law, the protocol, and provided the pregnancy is of less than 9 weeks duration, the woman is given the choice of either taking misoprostol at home, or coming back to the clinic to take misoprostol under medical supervision.
Women opting to self-administer misoprostol at home will receive information and counselling. In addition, it may be useful to provide the patient with an information leaflet with details of what to do and how to take care of herself through the abortion process. The woman should be instructed to call her provider with any questions or problems, if at all possible, rather than seek emergency care, as emergency room personnel may not be familiar with medical abortion, and the woman may end up having an unnecessary surgical procedure. (See Annex 1 for a sample patient information leaflet).
Pain relief during medical abortion
The abortion process causes pain. It is most likely to be felt in the first hours after administration of misoprostol, when the gestational sac/embryo is being expelled from the uterus. Studies have shown that women feel less pain if they are older, have been pregnant before or are in the early stages of pregnancy. However, none of these factors is sufficiently predictive to be useful in the management of individual cases.
The perception of pain and request for relief vary greatly from one individual to another and between cultures. Pain is also dependent on duration of pregnancy. Health care providers should make adequate analgesia easily available to all women who request it during medical abortion. Examples of commonly used preparations are: paracetamol 500–1000 mg or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen 200 mg. In cases of severe pain, codeine 30–40 mg may be added to either of the above-mentioned treatments.
Second visit (if a woman up to 9 weeks opts to take misoprostol in the clinic and in all cases with pregnancies of more than 9 weeks duration)
If a woman with a pregnancy of up to 9 weeks decides to take the misoprostol at the clinic, she is provided misoprostol according to the regimen used after which she may be kept under observation in the clinic for 4-6 hours. During this time, more than 90% of women will have expelled the products of conception . If abortion does not occur within the observation period, the woman can go home to abort. Alternatively she may want to go home soon after administration of the misoprostol.
In first trimester pregnancies of more than 9 weeks duration, four pills of 200 micrograms misoprostol are administered vaginally, followed by additional doses of the drug vaginally and/or orally until abortion takes place, as per the recommended regimen. The woman is kept under observation until several hours after she expels the products of conception.
All women should be given:
It is important to confirm that the pregnancy has indeed been terminated after medical abortion. If expulsion of the products of conception was confirmed by a qualified person in the hours after administration of the prostaglandin, further follow-up is not absolutely necessary. Otherwise, a follow-up visit should be arranged about two weeks after the administration of mifepristone, at the convenience of the woman.
At the follow-up visit, complete abortion should be confirmed clinically by bimanual pelvic examination. If serial measurements of human chorionic gonadotrophin (hCG) in blood or urine are used, it should be remembered that in some cases low hCG levels can be detectable for up to four weeks after successful expulsion. Women may need to be referred for ultrasound scanning if there is reason to suspect failed abortion. Women who continue to have symptoms of pregnancy and/or who have had only minimal bleeding are likely to still be pregnant.
8. Management of side effects and complications
Heavy or excessive bleeding
Vaginal bleeding occurs as part of the abortion process. For most women, vaginal bleeding starts between one hour and seven hours after they take misoprostol. Bleeding is heavier than menstruation while abortion is occurring and the products of conception are being expelled. This heavy bleeding lasts only for a short duration, about 1-4 hours, and tapers off. Some women may experience a second episode of heavy bleeding a few weeks after they have aborted ; this very rarely happens and cannot be predicted.
Bleeding is excessive if two thick sanitary pads get soaked with blood within one hour, and this happens two hours in a row. When signs of hypovolemia are present: light-headedness, dizziness, weakness, fatigue or tachycardia, intravenous fluids should be administered . If heavy bleeding continues, surgical intervention may be required.
Blood transfusion should be provided only if medically required and not as part of routine management. Only about
It should be noted that some women may present with bleeding after self-administering misoprostol, particularly in settings where access to abortion is legally restricted. The clinician should evaluate whether abortion has already occurred and whether any further intervention is necessary.
On average, vaginal bleeding gradually diminishes over about two weeks after a medical abortion, but in individual cases spotting can last up to 45 days. Generally, bleeding after medical abortion lasts longer than after vacuum aspiration. If the woman is well, neither prolonged bleeding nor the presence of tissue in the uterus (as detected by ultrasound) is an indication for surgical intervention. Remaining products of conception will be expelled during subsequent menstrual bleeding. Surgical evacuation of the uterus may be carried out at the woman’s request or if the bleeding is heavy or prolonged, or causes anaemia, or if there is evidence of infection.
Genital infection should be excluded prior to the abortion treatment. The genital tract is more susceptible to ascending infection when the cervix is dilated after abortion or childbirth. There are few data on the incidence of clinically significant pelvic infection after medical abortion, but it seems to be rare and probably occurs less often than after vacuum aspiration. Many of the symptoms of pelvic infection, such as pain, are rather nonspecific and hence precise diagnosis is difficult. Women with clinical signs such as pelvic pain, abdominal or adnexal tenderness, vaginal discharge and fever should be treated with broad-spectrum antibiotics .
Infection may be suspected if a woman:
When infection is the result of retention of products of conception, the woman needs to be given oral antibiotics and a surgical abortion should be performed. If infection is severe, then hospitalization and parenteral antibiotics may be required .
A number of recent deaths reported in the
If there is reason to suspect that pregnancy is ongoing when the woman returns for a follow-up visit within 14 days of taking mifepristone, a clinical examination, a beta hCG blood test (if the previous titre is unavailable) or an ultrasound examination may be performed. The provider should always consider the possibility of an ectopic pregnancy.
If pregnancy is ongoing, the provider may give the woman the option of further medical treatment (appropriate to the gestation of the pregnancy), or a surgical abortion. If a woman wishes to continue with her pregnancy after a failed abortion, she should be informed of the risk of birth defects .
Health providers who are new to providing medical abortion may tend to intervene with surgical abortion much earlier than warranted. It is important to remember that about 10% of women may not begin to bleed within the first 24 hours following misoprostol. In most instances, waiting for a few more days and/or giving an additional dose of misoprostol may be adequate. Aspiration abortion may be needed only if tests show pregnancy to be ongoing at the time of the follow-up visit. The decision to perform aspiration should not be based on ultrasound findings unless a persistent gestational sac is identified.
Risk of fetal abnormality after a failed medical abortion
Only one anomaly has been reported after the use of mifepristone alone. This case, described as a sirenomelia , could not be related to the drug intake. Indeed, this type of anomaly occurs at an earlier stage of pregnancy than the time when the drug is taken Thirteen other cases of malformation have been reported; all occurred in pregnancies in which mifepristone was administered at 7–9 weeks of amenorrhoea, followed in eight cases by gemeprost and in five cases by misoprostol. None of the events could be conclusively related to the treatment .
It is not possible to determine whether the reported anomalies were caused by the treatment, since the incidence of birth defects in a normal population is around 2 per 100 births . Some prostaglandins have been classified as teratogenic, although misoprostol did not induce such effects in embryo toxicology studies . Mifepristone is not teratogenic but when used in combination with a prostaglandin, it may induce uterine contractions, which could account for some of the observed defects . Since the available data are limited and inconclusive, there is no need to insist on termination of an exposed pregnancy if the woman wishes to continue it. Women should, nevertheless, be informed that, because it is unknown whether there is a risk of abortifacient drugs to the fetus, follow-up is important.
Caution is needed in the use of misoprostol alone for pregnancies in the second trimester. The dosages of misoprostol must be reduced as the duration of pregnancy increases, because beyond 16 weeks, the uterus becomes very sensitive to prostaglandins. There is a risk of rupture of the uterus after 16 weeks of pregnancy and particularly in women who have a scar from a previous caesarean section .
|BOX 1: Up to 9 weeks (63 days of pregnancy)|
|BOX 2: Over 9 weeks (63 days) of pregnancy: (9-13 weeks and 13-24 weeks)|
|3. Basic requirements in a health facility for providing medical abortion services|
1. Regulations covering abortion
In almost all countries, there are regulations governing health facilities and personnel providing surgical abortion. These specify infrastructural facilities needed and personnel authorised to provide abortions, and where abortion is legal they may require regular reporting by the health facility to the health authorities of the state/country. In many instances, these regulations may need to be updated to include appropriate requirements for medical abortion. These include cadre of providers who can provide medical abortion, training requirements and infrastructure, and resources needed for provision of medical abortion.
2. Approval of mifepristone and misoprostol and registration of the drugs by pharmaceutical companies
One of the major issues for which advocacy is needed is for approval by the national drug regulatory agency of mifepristone and misoprostol for medical abortion and other gynaecologic and obstetric indications, and encouraging multiple pharmaceutical companies to register and distribute both products in the country. Since abortion is legally permitted for some indications in almost all countries, licensing and availability of mifepristone and misoprostol are needed so that women who have grounds for legal abortion can have access to the method.
Historically, only physicians have been authorised to provide abortions. Now that both aspiration and medical abortion procedures are greatly simplified, it is now feasible to enable provision of both medical and aspiration abortion services by trained mid-level providers, under the supervision of a physician. It is common medical practice for physicians to delegate the dispensing of medications to other health care professionals under their supervision . Medical abortion can be safely provided by nurses and midwives. In France, Great Britain and Sweden, these mid-level providers are responsible for many aspects of the medical abortion process , including information provision and contraceptive counselling and provision. In 15 states in the United States to date, regulations have been amended to allow nurse-midwives, nurse practitioners and physician assistants to be trained and they are now providing medical abortions in all those states. .
In Sweden, midwives provide counselling on abortion methods and contraception, administer mifepristone and misoprostol and pain treatment as well as doing the follow-up after treatment , while in Great Britain, nurses may administer mifepristone and misoprostol but a physician has to prescribe them .
Based on this experience, South Africa recently updated its abortion regulations to allow trained mid-level providers to manage the whole medical abortion procedure . This shift in policy will greatly increase access to early abortions for women, especially where physicians are in short supply. It will also greatly help to reduce the cost of service delivery.
Experiences of adapting and demedicalising health technology and interventions for the management of malaria and tuberculosis, providing contraceptive services and treating obstetric emergencies show that non-physician, mid-level providers can play a significant role in making life-saving technology accessible even to those living in remote areas of developing countries. Medical abortion is a low-technology procedure that can be safely provided by mid-level providers who may or may not be skilled in surgical evacuation procedures. Few complications occur and only rarely is emergency referral to appropriate back-up facilities needed, including in developing country settings . In case of method failure, it is adequate if there is an assured referral link to a physician or a back-up facility.
4. Knowledge and skills needed
All health providers responsible for providing medical abortion need to have training, including the following knowledge, skills and values :
It is important to note that a medical abortion provider need not be skilled in providing aspiration abortion. Yet, a study in the USA found that general practitioners, who have been referring women to specialists for aspiration abortion tended to refer women also for medical abortion. Many said it had never occurred to them that they could themselves provide medical abortion .
Providers of surgical abortion may not be trained to give information and where requested counsel women seeking abortions. This should not discourage providers from adding medical abortion to their range of services. There are several ways of addressing this issue. The physician may seek training in counselling and communication skills to make this an integral part of patient-provider interaction. Alternately, other staff in the health facility, mid-level providers as well as paramedics, may be trained to provide information and offer counselling to all women seeking abortion.
5. Health facility setting and infrastructure
Medical abortion can be safely provided in primary health care settings and other out-patient facilities, including private offices of practitioners, particularly when the protocol includes administration of the misoprostol by the woman in her home. For example, regulations in France have been modified to permit providers in licensed private facilities to do so (www.fiapac.org). The space, however limited, should be so arranged as to ensure both visual and auditory privacy for the woman seeking abortion, during consultation with the health provider and during counselling.
Procedures need to be in place for ensuring patient confidentiality. Information disclosed to any staffperson in the health care setting should be protected and made available only to other staff directly involved in the patient’s care. Patient files should be stored in secure spaces not accessible to those not directly involved in patient care.
Basic amenities such as a working toilet and a comfortable waiting area with seats are a must. Adequate numbers of toilets and arrangements for provision and disposal of sanitary pads and the products of conception are especially important if misoprostol is being administered in the health facility.
Facilities for carrying out basic tests prior to administering the drugs are important. Facilities are also needed for performing bimanual pelvic examinations – an examination table, sterile instruments, adequate privacy and a health provider competent to perform the examinations and interpret the findings.
After provision of medical abortion in the first trimester of pregnancy, it is sufficient if a mid-level provider or a physician is available for consultation in person or over the phone in case women have any concerns. With second trimester abortion, a physician should be available on the premises throughout the process.
Provision of medical abortion does not require emergency services onsite. For both first and second trimester medical abortion, good links with referral health facilities that can provide inpatient and/or emergency medical care for the small proportion of women who may need it are adequate. Modest inpatient facilities with a few beds and facilities for overnight stay are required if second trimester medical abortion is to be provided.
6. Equipment, supplies and commodities
At a minimum, the following should be available:
It is not essential for health facilities offering medical abortion to have ultrasound scanning equipment on the premises. Routine ultrasound scanning is not required for medical abortions.
7. Time considerations
Some health care providers have expressed concerns that medical abortion will be a time-consuming procedure . However, most of the time involved is in giving the woman information, giving her the tablets and supporting the woman while she is waiting for the abortion to take place, much of which does not necessarily require direct attendance by the actual provider, but can be provided by auxiliary health staff.
8. Referral services and emergency care
The health facility providing medical abortion services should give women information on what to do in case of a medical emergency.
Women may need to be referred for ultrasound scanning when there is doubt about duration of pregnancy or reason to suspect failed abortion. There should be referral linkages with appropriate facilities where women can receive a surgical evacuation in case of method failure or emergency care. Existing emergency obstetric care facilities can play this role.
9. Who is responsible for ensuring access to abortion services?
It is the responsibility of the public health system to ensure that all women seeking abortion within the national legal context and all women requiring post-abortion care have access to it, either through public health facilities, including the primary level as feasible, or through non-profit or other private clinical facilities.
1. Basic principles
Counselling is a communication process between a woman and a health care provider that supports the woman to achieve her reproductive decisions. Each woman needs information on the medical and aspiration abortion processes, and where possible she should be offered a choice between them and prepared for whichever procedure she opts for. Most women have made up their own minds that they want an abortion; they do not need to “explore” their decision with the provider. It is usually very clear when a woman is unsure, e.g. whether or not to have an abortion or which abortion procedure to have, and then counselling can help the woman to reach her own decision. This situation is sometimes precipitated by the parents of young women, parents-in-law of young married women or by partners who seek to influence the woman’s decision one way or another. Counselling in this situation should be done in a non-directive way, with the aim of supporting the woman .
Counselling may also include discussing any topics relating to the woman’s (or couple’s) experiences and concerns such as health-related fears, future plans, religious or spiritual values, and any misconceptions she may have about abortion or contraception. Good counselling always needs counsellors to be sensitive to and involved with the situation and feelings of each woman. It requires flexibility, empathy and skills, which must constantly be strengthened.
Counseling and information provision do not always find a place of priority in abortion services. Barriers include:
All of these can be addressed if adequate investment is made in training and staffing, and if counselling is included in the standard protocol for provision of medical abortion services.
2. Content of information to provide on medical abortion
The following information is essential to provide and discuss with the woman during pre-abortion counselling:
Some points to be emphasised may be:
The woman then needs to decide which abortion method is best suited to her.
3. Informed consent
Ethical provision of abortion services, as with all medical care, requires obtaining formal informed consent from the woman having an abortion. Most informed consent forms ask the patient to affirm that she consents to undergo the procedure voluntarily after receiving full information about the procedure, eligibility criteria and side effects and complications.
An informed consent form should contain the following details:
Labelling information for mifepristone in many countries requires that each patient receive information about the product and sign a Patient Agreement, similar to an informed consent form.
In settings hostile to the provision of abortion services there is a possibility that the informed consent procedure is abused in order to try to put women off having an abortion. For example, abortion consent laws in some states of the US include biased language, exaggeration of or inaccurate statements of health risks and impose cumbersome procedures .
4. Information after mifepristone is given
After the woman receives mifepristone, she should be given the following information before she leaves the clinic:
6. Follow-up visit
For many women the period between taking of the drugs and the follow-up visit is stressful. When successful termination of pregnancy is confirmed, there is a great sense of relief . However, some new questions may have arisen that need to be addressed, such as feelings related to the products of conception seen by the woman. During this visit, questions may be asked to ascertain whether the woman has started using contraception, and to encourage her to do so if she has not already done so. Those planning to use hormonal or barrier methods should be provided with adequate supplies and IUD insertion may be done for women who have opted for this method. Or, an appointment can be given for a sterilisation (or vasectomy for the woman’s partner).
For a small proportion of women whose abortion is incomplete or who are experiencing ongoing pregnancy, counselling support may be needed to prepare them for a further intervention. Women who opted for medical abortion because they were keen to avoid anaesthesia or an invasive procedure may need particular support if their only option is a surgical intervention.
With a failed medical abortion, some women decide to continue the pregnancy to term. It is important to advise them of the risk of birth defects and the possibility of spontaneous miscarriage. Future follow-up with ultrasound examination to screen for fetal malformations should be considered.
The decision to have an abortion can be a difficult one. If women feel stigma and shame, they may be less likely to ask questions of the provider or come for a follow-up visit. It is important to help them feel empowered by their decision, and the importance of voluntary motherhood.
7. Self-administration of misoprostol at home
For women who will be self-administering misoprostol at home, the following information and counselling should be given:
During this stage the women may worry about bleeding and cramps. Support is important for women who will be self-administering misoprostol at home.
|BOX 3: Principles of women-centred counselling|
|BOX 4: Rights of women seeking abortion|
|5. Training for providing medical abortion|
The limited number of health care providers trained to provide medical abortion is one of the most important bottle-necks to the availability of medical abortion.
Health professionals’ organisations and health care providers with relevant authority can help to increase the number of trained providers of medical abortion by organising observation and exposure visits for providers wishing to offer medical abortion and set up an effective medical abortion training programme at their health facilities. It is also imperative to advocate for mid-level clinicians to be able to provide medical abortion in both public and private sectors.
Some issues to consider when planning for medical abortion training in a health facility include :
Training workshops on medical abortion can also be included as part of Continuing Medical Education (CME) programmes. Teachers of undergraduate medical students, midwives and nurses are well placed to integrate basic information about medical abortion within the curriculum. They may also use a number of extra-curricular forums to expose students to information about abortion in general, and medical abortion in particular. Training workshops for medical students that go beyond clinical skills and seek to influence attitudes, address social and ethical issues related to abortion and improve communication and counselling skills are also important.
A range of resources for medical abortion training have been produced by the National Abortion Federation (US), and are accessible online at: www.prochoice.org/education/resources/med_educational_resources.html
An excellent training curriculum is also available at: http://www.ansirh.org/_documents/training/earlyabortiontrainingworkbook-trainees.pdf
The Clinician Training Initiative launched in 1993 by the Planned Parenthood Association of New York City (PPNYC) in the US offers training on abortion, including medical abortion. Its counselling guide for clinicians offering medical abortion has become a standard reference in the field and can be found at: http://www.plannedparenthood.org/index.htm
|6. Promoting access to medical abortion in health systems|
1. Promoting access to safe abortion: the role of service providers
Advocacy may be defined as “the act or process of supporting a cause or issue” . Health professionals have played a pivotal role in many countries of the world in advocating for making abortion services safe and legal, and for expanding access to safe abortion services. They have also been at the forefront of promoting access to medical abortion in many countries, including developing countries such as China, India, Kenya, Nigeria, South Africa, Tunisia, Turkey and Vietnam.
For example, in Kenya, the Private Providers Network of Western Kenya (PPNWK) recruits and trains private physicians, mid-level providers and community health workers to provide comprehensive post-abortion care. This is an example of successful networking and advocacy within the professional community to improve the quality of post-abortion care in a context where legal restrictions permit abortion only to save the life of the woman .
In Nigeria, the Campaign against Unwanted Pregnancy (CAUP) was initiated by a team of three medical doctors who were seeing many women die or suffer grievous health consequences from complications of unsafe abortions. Launched in 1991, over a period of 14 years CAUP has succeeded in placing unsafe abortion firmly on the political agenda and its members have carried out ground-breaking research on abortion in Nigeria and trained health providers in treating abortion complications. CAUP continues to advocate for changing the abortion law from a legally restrictive to a more liberal one .
Organisations such as Clinicians for Choice and Medical Students for Choice in the US and Doctors for a Woman’s Choice on Abortion in the UK are examples of initiatives by health care providers to expand access to abortion through legal changes and advocacy within the profession.
This section draws on these experiences to present some examples of ways in which health providers and health managers can advocate for medical abortion, and/or contribute to the advocacy process through training and research.
2. An advocacy agenda on medical abortion for health care providers
· Reform of restrictive laws, policies and regulations.
In addition, where malpractice insurance for clinicians is a major issue, as in the United States, physicians must advocate to have medical abortion included in their general coverage, rather than as part of an expensive obstetrics-gynaecology package, which makes medical abortion prohibitively expensive for primary care clinicians who do not otherwise provide obstetric services.
3. Approaching supportive policy-makers
4. Information dissemination
5. Clinical and introductory trials
Research and documentation represent a powerful means of influencing policy-makers and fellow health care providers. One of the ways health care providers have influenced the approval, registration and introduction processes for medical abortion is to conduct national or local clinical and introductory trials.
Introductory trials take place after the safety and effectiveness of a new method has been established through initial clinical trials. Clinical studies and introductory trials carried out in India, China, Sweden, the United Kingdom and Vietnam, for example, were instrumental in gaining support for the national introduction of medical abortion for pregnancy termination. Introductory trials may examine safety and effectiveness in the national or local setting, but usually focus more on the acceptability of medical abortion and on service delivery requirements. A recent introductory trial in Turkey, for example, found that 75% of women who chose medical abortion opted for home use of misoprostol and 90% of women who had medical abortion said they would prefer it again if they had to have another abortion. Such findings supported the introduction of early medical abortion in Turkey .
Not only professional researchers but all health providers can have a role in adding to the body of knowledge on medical abortion services. They can do so by carrying out service delivery research based on data from clinic logbooks, observation of counselling sessions, interviews with women and providers, feedback forms and staff discussions.
|7. Medical abortion in legally restricted settings|
Women seeking an abortion in a setting where abortion is legally restricted may be left very much on their own through all or part of the abortion process, no matter what abortion method is used and no matter what sort of provider they have seen, if any. Mifepristone is very unlikely to be available in such settings, and misoprostol will therefore be used alone unless the provider can prescribe methotrexate.
It is important that pharmacists, midwives, nurses and clinicians are aware of how misoprostol can be used as safely and effectively as possible. When women are self-administering medical abortion, clinician’s may have concerns about women taking control of their own health care. This can result in an unwillingness to share information about correct dosages. However, this is a mistake. Using a harm reduction model, they should advise and help women to avoid unsafe outcomes. See an example in the box 5.
Clinicians and other providers doing abortions unofficially will be overwhelmingly private providers or public providers working in private settings. Providers also need to protect their own professional positions and may or may not be in a position to see women through the whole process. Resources for follow-up care may also be limited to a greater or lesser extent because of legal restrictions.
Unsafe abortion is a public health scandal that can only be resolved through making abortion legal and safe.
|BOX 5: A risk reduction strategy to prevent maternal deaths associated with unsafe abortion|
In a public hospital in Montevideo, where unsafe abortion was causing 48% of all maternal mortality, a group of obstetrician−gynaecologists developed a programme called Public Health Initiative against Unsafe Abortion. This programme includes two interventions to reduce the risks associated with unsafe abortion. The first is to offer a consultation to any woman presenting with an unwanted pregnancy or self-identifying as at risk of unsafe abortion. Women attending this “before visit” have gestational age confirmed by ultrasound and assessed for any legal grounds for termination. In the case of healthy pregnancies which do not meet the legal criteria for abortion, women are given accurate information on the relative risks of a range of different abortion methods. The information includes the correct doses of misoprostol, which is available in Uruguay. No information is given on how to obtain the drugs. All women are encouraged to attend an “after visit”, either following abortion or for antenatal care. At that meeting, the woman can have a uterine aspiration if needed in the case of incomplete abortion (initially recorded in 30% of cases where misoprostol was used, but declining to 18% as the programme continued), and provision of an effective contraceptive method. Women began to self-refer to this programme as news of its existence was disseminated by word of mouth; others were referred by health workers in primary care or hospital clinics. The programme began in March 2004. After six months, the Ministry of Health officially sanctioned the programme. 675 women were attending the “before visit” each month, with the number increasing each month. 73% of these returned for the “after visit”. 88.9% of the 439 women for whom information was available had gone on to have an abortion outside the hospital. 3.5% returned for antenatal care and the remaining 7.5% were no longer pregnant or met a requirement for legal abortion in hospital. All the women who had had an abortion and attended the “after visit” reported using misoprostol. There were no maternal deaths or severe complications recorded at the hospital during the programme period. Health care workers in countries where abortion is illegal or severely restricted are not able to change the law. However, implementing risk reduction strategies such as this one, which gain the confidence of women, can prevent suffering and complications and reduce the cost of treatment to the public health services .
|8. Annex 1. Sample patient information leaflet|
Today, ______________________ you have taken a pill called mifepristone to end your pregnancy. You took 200 milligrams of mifepristone at _______ am/pm. You will probably not feel different after taking this pill. You may have some vaginal bleeding.
a) FOR THOSE SELF-ADMINISTERING MISOPROSTOL AT HOME
Anytime between 26 to 48 hours from now, between ______ am/pm on ____(date) and _____ am/pm on ______(date), you will put 4 pills of another medicine, misoprostol, in your vagina. You must insert the misoprostol even if you have already started to bleed. Each misoprostol pill is 200 micrograms. Choose a time when you have had a good meal and plenty of rest.
After putting these pills in your vagina, you should lie down for at least 30 minutes while the medicine gets absorbed into your body. Don’t worry if the pills fall out after 30 minutes have passed.
b) FOR THOSE RETURNING TO THE CLINIC FOR MISOPROSTOL
You are to return to the clinic 26 to 48 hours from now, between ____am/pm on ______(date) and ______am/pm on _____ (date). At that time Misoprostol will be inserted vaginally by the physician. You will also be scheduled for your final follow-up visit at this time.
Drink plenty of fluids (avoid alcohol), and eat lightly.
Monitor your bleeding. Un-dissolved tablets can come out after you begin to bleed; however, in most cases enough of the tablets have been absorbed in order for them to still be effective.
When to call for help
Most women (90%) have completed the abortion by the date of their check-up. If your pregnancy has continued (about 1%) a suction abortion will be scheduled as soon as possible. If your pregnancy has not continued, but has not passed from your uterus (about 5%), you may either:
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