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 [1] and an estimated 5 million women per year are hospitalized for complications of unsafe abortion [2]. 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:

• prompt, high quality and humane medical services to treat the complications of unsafe abortion;
• compassionate post-abortion counselling and family planning services to promote reproductive health, reduce unwanted pregnancies and prevent repeat unsafe abortions and;
• safe abortion services in circumstances where they are not against the law [3].

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.” [4]   

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 [5]. 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 [6].

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 [7]. 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 [8].  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 [9]. 

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 [10].

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1.  Drugs used for medical abortion

Combination of two drugs

The most commonly used combination of drugs for medical abortion is

• mifepristone, taken first, and
• misoprostol,  given 24-48 hours later.

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 [11]. 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) [12]. Although the efficacy of vaginal administration is less sensitive to administration intervals, the data from pharmacokinetic studies [13] 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 [12].

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 [14]. 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 [15], [16], [17], [18], [19], [20].

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  [15], [20].

3. Contraindications

Absolute contraindications

There are very few absolute contraindications to medical abortion. When using a combination of mifepristone and misoprostol they include:

• known or suspected ectopic pregnancy;
• previous allergic reaction to one of the drugs;
• inherited porphyria;
• chronic adrenal failure; and/or
• haemorrhagic (coagulation) disorder.

Caution is required if the woman:

• is on long-term corticosteroid therapy;
• has severe anaemia; and/or
• has pre-existing heart disease or cardiovascular risk factors.

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 [21], and the incidence of heavy bleeding may be higher as well as the duration of bleeding [22].

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 [23].

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 [24].

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 [25].

4. Safety

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 [26]. 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 [27], [28]. 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) [29]. 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 [30].

The most common problems reported at follow-up or unscheduled visits are continued pain and vaginal bleeding and discharge [31]. 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 [32], 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).

   5. Regimens

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 [30], [33], [34], [35]. Therefore, the approved regimen (license) in Europe has now been revised (Exelgyn, mifepristone license 2007). Some studies have indicated that mifepristone can be given as five or six divided doses of 25 mg over three days, for a total dose of 125–150 mg [36]. This regimen is widely used in China and has been shown to be effective up to 49 days of gestation, when used in combination with misoprostol. However, for both patient and service delivery convenience, the single dose of 200 mg of mifepristone is preferred.

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 [37]. 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 [14], [38]. 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 [28], [39], [40].

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. 

Vaginal administration of misoprostol is more effective and associated with fewer side-effects than oral administration of the same dose [27], [31], [39], [41].

In some studies, repeated doses of misoprostol have been used, either routinely for all women or in those with evidence of incomplete abortion [27], [28], [42]. 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 [43].

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 [27], [44] 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 [45]. 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 [46], [47]. The 24-48 hour interval can also be used in second trimester abortion [48], [49],  [50].

6. Pre-abortion management

Counselling

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

Treatment with mifepristone and misoprostol typically involves two or three clinic visits by the patient for pregnancies up to 9 weeks, and three clinic visits for pregnancies above 9 weeks .

First visit

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 [15]. 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:

• appropriate pain relief in case it is required, with instructions on dosages and when and how to take it.
• written information on the abortion method, side effects and signs and symptoms of complications that need medical attention [52].
• a letter and a printed fact sheet with sufficient information about the procedure to allow another practitioner to deal with any complications, and provider contact information in case of questions or complications.
• an information leaflet (See Annex 1) on after-care.
• sanitary pads or cotton wool.
• reminder for the follow-up appointment.
• contraceptive information and choice of a method.

Follow-up visit

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 [53]; 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 [54]. 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 1 in 1,000 women experience bleeding so heavy that they need blood transfusion [53].

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.

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 [32].

Infection may be suspected if a woman:

• develops a fever of 38o C (100.4o F) or higher, that lasts for more than 4 hours,  or a fever starts 6−8 hours after she has taken misoprostol
• has severe abdominal pain
• has pelvic tenderness.

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 [53].

A number of recent deaths reported in the United States and one in Canada following medical abortion were associated with infection from the anaerobic bacteria Clostridium sordellii. The U.S. Centers for Disease Control held hearings in May 2006 and found no evidence that these deaths were linked to the women having been administered either mifepristone or misoprostol. No other cases have been reported among women who have used medical abortion worldwide to date (data from China, where more than 22 million women have used medical abortion, are not available). Twelve other cases of Clostridium sordelli have been identified in ob/gyn cases in the United States, including eight cases of post-partum infection, three cases of spontaneous abortion and one case of endometritis. All but one of these infections was fatal. Research on the apparent increase in Clostridium sordellii infections in the US has recently begun [55], [56], [57],  [58].

Ongoing pregnancy

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 [59].

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 [60], 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 [61].

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 [62]. Some prostaglandins have been classified as teratogenic, although misoprostol did not induce such effects in embryo toxicology studies [63]. 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 [64]. 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.

Uterine rupture

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 [65].

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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.

3.    Personnel

Historically, only physicians have been a