|
| 1. Introduction |
|
For centuries, women everywhere in the world have felt entitled to terminate unwanted or mistimed pregnancies, and used whatever means were known and available to them to do so. The development of modern medical technology has now made it possible for women to terminate a pregnancy surgically without jeopardising their lives and their health. 
An alternative to surgical abortion, a combination of two drugs (“abortion pills”) which induce abortion was first licensed in France in 1988. One of the two drugs, Mifepristone, is now (2005) licensed in 35 countries . More than 22 million women in China and about four million in the rest of the world have used the method to terminate a pregnancy, and have found it safe and effective [1].
The second drug, Misoprostol, is registered for the prevention of gastric ulcers induced by the use of non-steroidal anti-inflammatory drugs in over 80 countries [2]. Thus, misoprostol is available in countries where mifepristone is not yet registered.
In many countries, including those with legal restrictions or limited access to abortion, one or both of these drugs are available across the counter in pharmacies. Recent studies have shown that many women, especially in countries where access to abortion services is limited, need more information about the abortion pills. This fact sheet, presented in a question-and-answer format, answers in simple terms questions that women usually ask about ‘abortion pills’. It aims to inform women about drugs that can safely and effectively be used to bring about an abortion, so as to enable them to make informed decisions about termination of pregnancy. In countries where abortion is legally available, it is safest if women use these drugs under the guidance of a health provider, if possible.
|
|
| 2. What is medical abortion? |
|
Medical abortion is the termination of pregnancy through the use of a drug or a combination of drugs.
|
|
| BOX 1: Emergency contraception is not the same as medical abortion |
|
Pills used for emergency contraception (EC), also known as the ‘morning-after’ pill, are used to prevent pregnancy through an effect on ovulation but do not disrupt pregnancy. Medical abortion, on the other hand, induces abortion in women who are already pregnant.
EC pills consist of a progesterone-like hormone in much higher doses than in oral contraceptive pills. They are for use by a woman if:
- neither she nor her partner has used a method of contraception at their most recent intercourse OR
- they fear that the contraceptive used has failed (e.g. the condom broke or slipped off in the vagina)
- sexual intercourse was within the past 120 hours.
It is advisable to take EC pills as soon as possible after unprotected sexual intercourse. The sooner they are taken, the more effective they are. If not taken within 120 hours, then EC is not likely to prevent pregnancy. EC pills are less effective in preventing pregnancy and have more side effects than most forms of regular contraception. After use the EC pills do not protect against further acts of unprotected intercourse.They are therefore not considered suitable for routine use.
( For more information on emergency contraception, refer to www.cecinfo.org )
|
|
| 3. What drugs are used for medical abortion? |
|
Mifepristone and misoprostol
The most commonly used combination of drugs for medical abortion is
- mifepristone, an anti-progestogen drug, taken first, and
- misoprostol, a prostaglandin drug , taken 24-48 hours later
Mifepristone causes the thinning of the uterine lining and softening of the cervix and combined with misoprostol causes strong contractions in the uterus. Together, the drugs cause the products of pregnancy to be expelled. The result is very much like a spontaneous abortion or miscarriage [3].
Mifepristone is commonly available as “Mifiprex”, “Mifegyne” or “Mifegest”. It is sold under several other brand names in India and China. Misoprostol is commonly available under the names Cytotec, Oxaprost or Cytoprost.
Misoprostol alone
In some settings, the prostaglandin misoprostol alone is used for medical abortion. This is often because mifepristone is not available or not affordable. When misoprostol alone is used, it causes uterine contractions, softening of the cervix and the products of pregnancy are expelled. But without mifepristone pre-treatment, a higher dose of misoprostol is needed. The abortion process can take longer and be more painful, with more side effects [3]. The likelihood of a complete abortion is also somewhat lower than in combination with mifepristone. But misoprostol remains a safer option than other dangerous and invasive methods of abortion that women resort to when safe abortion services are not available.
Methotrexate and misoprostol
In countries where mifepristone is not available, methotrexate has been used in combination with misoprostol. However, methotrexate is not recommended by the World Health Organization (WHO) for inducing abortion, because of concerns that it may increase the risk of fetal malformation in a continuing pregnancy [4]. It also involves a more prolonged abortion process.
|
|
| 4. When during a woman's pregnancy can medical abortion be used? |
|
Medical abortion can be used from very early in pregnancy up to 24 weeks counting from the first day of the last menstrual period (LMP) [4]. However, the dosage and regimens change at 9 weeks, for 9-13 weeks and for 13 -24 weeks of pregnancy [5].
|
|
| 5. Are there any women who cannot use medical abortion? |
|
It is advisable for a woman not to use the mifepristone/misoprostol regimen for medical abortion if she has any one of the following health conditions [6]:
- Her health provider suspects or has confirmed that she has an ectopic pregnancy (see BOX 2).
- She has an allergy to mifepristone
.
- She has an allergy to misoprostol
.
- She has a disease or condition affecting blood\'s ability to clot.
- She is taking drugs for thinning the blood.
- She is taking certain steroid drugs. If she is taking drugs orally or as injections for treating chronic arthritis, asthma and other allergic conditions, she should check to see if these are (or contain) corticosteroids. If in doubt, her health provider may be consulted.
- She suffers from chronic failure of adrenal glands. Adrenal glands are small, triangular glands located on top of the kidneys and produce a variety of hormones including adrenaline, essential to help the body cope with stress.
- She has inherited porphyries, which is an uncommon disorder of certain enzymes responsible for the formation of the iron-containing pigments in proteins.
None of the above conditions, apart from allergy to misoprostol, applies to the use of misoprostol alone.
If a woman has an IUD in place in the uterus, this should be removed prior to use of medical abortion with mifepristone/misoprostol combination or with misoprostol alone.
Women with mild to moderate anaemia (haemoglobin levels between 9 and 12 gm/dl) can use medical abortion. However, it may be beneficial for women with mild to moderate anaemia to take iron pills when using medical or surgical abortion.
|
|
| BOX 2: Ectopic pregnancy |
|
An ectopic pregnancy is a condition where a fertilized egg settles and grows in any location other than the inner lining of the uterus. The vast majority of ectopic pregnancies occur in the fallopian tube (95%); however, they can occur in other locations, such as the ovary, cervix or abdominal cavity [7].
Ectopic pregnancy can be asymptomatic in the initial stages. Symptoms of an ectopic pregnancy can often be vague, and include vaginal bleeding, abdominal or pelvic pain (usually stronger on one side), shoulder pain, weakness or dizziness. These symptoms can also occur in other conditions such as ovarian cysts, miscarriages, or even in normal pregnancy.
Occasionally, the doctor may feel a tender mass during the pelvic examination. If an ectopic pregnancy is suspected, beta hCG blood tests, and ultrasound can be used to help confirm the diagnosis [7].
|
|
| 6. Can a woman use a medical abortion if she is breastfeeding? |
|
There is some evidence that mifepristone is excreted into breastmilk but little evidence regarding any effect on the adrenal function of the infant. The evidence that is available suggests that the amounts of mifepristone ingested by the infant are unlikely to cause harm [8].
Small amounts of misoprostol 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 and the next feed given after four hours in case of oral administration of misoprostol and somewhat later after vaginal administration [9].
However, if a woman is worried that the drugs may be excreted in the breastmilk, she may discard her milk for 24 hours following the use of mifepristone/misoprostol or misoprostol alone.
|
|
| 7. Is medical abortion safe for women who are HIV positive? |
|
There is no reason why HIV positive women cannot use medical abortion. HIV positive women may be at higher risk of reproductive tract infections from retained products of conception, but this may occur with medical or surgical abortion.
They may also be at risk for anaemia, especially if they have malaria or are taking certain antiretrovirals (ARVs) and iron pills may be prescribed. The small proportion of women who develop heavy bleeding need to be treated promptly to avoid serious consequences [10].
|
|
| 8. Can adolescents use medical abortion? |
|
There is no medical reason why medical abortion may be unsuitable for adolescents. Medical abortion is more painful for anyone who has never been pregnant, and this may mean that young nulliparous women may need more pain medication than women who have previously given birth.
The availability of medical abortion can be especially helpful for unmarried adolescents and other young women who do not have access to safe surgical abortions in many countries.
|
|
| 9. Can a woman use a medical abortion if she has a reproductive tract infection? |
|
A woman may be aware that she has an infection of the reproductive tract (RTI) because she is undergoing treatment for it. Or, she may suspect she has an RTI because of the symptoms she is experiencing, such as foul-smelling white or yellow/green discharge, itching or sores in the genital area, or frequent urination with pricking pain. Treatment should not be delayed as untreated infection can have serious health consequences, including infertility.
During a woman’s first clinic visit for medical abortion, the health provider is required to take a detailed history and give a thorough physical examination, including pelvic examination. If an RTI is suspected, a laboratory test may be prescribed to confirm if the woman has a reproductive tract infection.
If a woman has an RTI, then she will be treated for the infection alongside use of medical abortion. The same is true when surgical abortion is carried out. There is no reason to wait for RTI treatment to be completed before either medical or surgical abortion.
|
|
| 10. Why do women choose medical abortion? |
|
Women choose medical abortion because of its following features [11], [12]:
- belief that it was safer
- more natural
- no surgery and/or anaesthesia
- one or both drugs may be taken at home
- can be used in the early stages of pregnancy
- easier and simpler
|
“I liked the tablets. See, I did not need to stay in the hospital. With curetting I would have spent two days there. I told my mother-in-law I was going to the market. I did not abort at the hospital although I waited for 3 hours. I was scared, would mother-in-law come to know? How many days I bled…I was going to the toilet every hour to check. See, we don’t have our own toilet. I felt embarrassed. But it happened when she was out. A little pain was there but that much is to be tolerated. Whatever you would have done, pain is always there. Everything has turned out well. I am very happy now. I will definitely use this method again. (Woman from India) [13]
“ ..Being outside of a doctor’s office makes you feel more in control, like you are not under somebody’s command. That this is my body, I’m in charge. I think actually the fact that you insert (misoprostol) yourself is a feeling like….this is my choice..my decision. There’s so much more power in it. (Woman from United States) [14].
|
|
|
| 11. How does a woman confirm that she is pregnant? |
|
Pregnancy can be confirmed with a pregnancy test. There are two types of pregnancy tests, blood and urine tests. Both tests look for a special hormone, human chorionic gonodotrophine (hCG) that is only present in the blood and urine when a woman is pregnant. The urine test may be performed at home using a pregnancy test kit, available from pharmacies, while the blood test can only be performed by a laboratory (See BOX 3).
|
|
| BOX 3: Pregnancy tests |
|
In most countries, a home pregnancy test kit is available. This is a urine test. If a woman tests positive in a home pregnancy test, it is fairly certain she is pregnant. If her test is negative, it may still be too early to detect the pregnancy because theamount of hCG in the urine is still too low. The urine test can detect pregnancy about a week to ten days after a woman has missed her last period [ 15].
The blood test for pregnancy is known as a beta hCG test. This measures the exact amount of hCG in the blood. This test is carried out in a clinical laboratory, on being prescribed by a health provider. The blood test can tell whether a woman is pregnant within just one or two days after she has missed her menstrual period [15].
A pelvic exam by a midwife or doctor can confirm pregnancy only around six weeks after a woman’s last menstrual period. She does not have to wait till then to confirm pregnancy. If a woman does not want to be pregnant, she may prefer to have a pregnancy test as soon as she has missed her period, and make arrangements to have an abortion.
|
|
| 12. How does a woman find out the number of weeks she has been pregnant for the purpose of seeking medical abortion? |
|
Women opting for medical abortion need to know how many weeks pregnant they are. This is because although dosage of mifepristone remains the same, the dosage and number of doses of misoprostol change at different stages of pregnancy.
The following methods are usually used for finding out the duration of pregnancy:
- Calculating the number of days that have elapsed since the first day of the woman’s last menstrual period. Many women make a note of the first day of each menstrual period on a calendar so that they can check it if needed.
- Having a pelvic examination carried out by a health provider. An experienced provider will be able to assess the duration of pregnancy through a pelvic examination starting from around six weeks LMP.
Ultrasonography may be used if:
- a woman is not sure of the date of her last menstrual period,
- she has become pregnant without resuming her period after an abortion or a delivery, or
- there are doubts about the duration of pregnancy even after the health provider has performed a pelvic examination.
With ultrasonography the size of the gestational sac and later in pregnancy, the length of the fetus can be measured.
|
|
| 13. How does medical abortion compare with surgical abortion in pregnancy up to 9 weeks? |
|
|
Medical abortion for pregnancy ≤ 9 weeks
|
Surgical abortion using vacuum aspiration for pregnancy ≤ 9 weeks
|
|
Can be used from 4 weeks LMP.
|
May not be available before 7 weeks LMP.
|
|
Resembles a natural miscarriage.
|
Involves inserting a tube into the uterus to aspirate the contents.
|
|
Abortion usually happens at home. If misoprostol is given in the health facility , abortion happens there.
|
Abortion happens in a health facility.
|
|
Abortion process lasts more than one day.
|
Procedure is completed within 10–15 minutes.
|
|
Takes at least two clinic visits.
|
Takes one to two clinic visits.
|
|
May be painful for 2-3 hours or more after using misoprostol.
|
May be painful during aspiration and afterwards when the uterus contracts.
|
|
Severe complications are rare.
|
Severe complications are rare.
|
|
Longer period of bleeding up to several weeks, although amount of blood lost is the same as with surgical abortion.
|
Shorter period of bleeding, as most blood is aspirated during the procedure.
|
|
Anaesthesia is not needed. Pain medication should be available.
|
Pain medication, light sedation and local anaesthesia should be provided , .
|
|
Most effective for pregnancy of less than 7 weeks.
|
Most effective in pregnancies of more than 7 weeks.
|
|
Woman may see blood clots and the products of conception.
|
Woman does not see products of conception.
|
[16]
|
|
| 14. What are the different regimens used for medical abortion up to 9 weeks of pregnancy? |
|
The following regimens are recommended for medical abortion from 4-9 weeks of pregnancy:
|
Oral mifepristone and oral misoprostol
Between 4 and 7 weeks of pregnancy [4]
|
Oral mifepristone and vaginal misoprostol
Between 4 and 9 weeks of pregnancy [5]
|
Misoprostol alone: vaginal or sublingual
Between 4 and 9 weeks of pregnancy [17]
|
|
Mifepristone: One 200 milligram pill , taken orally, followed by
Misoprostol: 400 micrograms (2 pills of 200 micrograms each), taken orally 24-48 hours after mifepristone .
|
Between 7-9 weeks, if bleeding does not occur within 4 hours after administration of misoprostol, a second dose of misoprostol 400 micrograms (2 pills of 200 micrograms each) may be inserted vaginally or taken orally.
|
Misoprostol 800 micrograms (4 pills of 200 micrograms each), to be inserted deep into the vagina,
Followed 3-6 hours later by a second dose of misoprostol 800 micrograms (4 pills of 200 micrograms each), inserted vaginally.
If abortion does not take place within 3-6 hours after the second dose, a third dose of 800 micrograms of misoprostol (4 pills of 200 micrograms each), can be inserted vaginally.
If the tablets are given sublingually, the three doses of 800 μg each are administered at 3 hour intervals [32].
|
|
|
| 15. What are the different regimens used for medical abortion after 9 weeks of pregnancy? |
|
The dosage of mifepristone/misoprostol varies for pregnancies of 9-13 weeks and 13-24 weeks.
The use of medical abortion after 9 weeks of pregnancy needs to be under medical supervision in a hospital or clinic setting because of increased risk of complications.
The following regimens have been recommended for medical abortion from 9–13 weeks and 13–24 weeks of pregnancy [5]:
|
Oral mifepristone and vaginal misoprostol
+ further doses of oral or vaginal misoprostol
Between 9 and 13 weeks of pregnancy
|
Oral mifepristone and vaginal misoprostol
+ further doses of oral misoprostol
Between 13 and 24 weeks of pregnancy
|
|
Mifepristone : one 200 milligram pill, taken orally, followed by
Misoprostol: 800 micrograms (4 pills of 200 micrograms each) to be inserted deep into the vagina 24-48 hours after mifepristone.
Further doses of 400 micrograms (2 pills of 200 micrograms each) of misoprostol, taken every 3 hours orally or vaginally (depending on the amount of bleeding) , to a maximum of 4 doses.
The woman is kept under observation in the clinic until several hours after she aborts.
|
Mifepristone: one 200 milligram pill, taken orally, followed by
Misoprostol: 800 micrograms (4 pills of 200 micrograms each), to be inserted deep into the vagina 24-48 hours after mifepristone.
Further doses of 400 micrograms of misoprostol (2 pills of 200 micrograms each), taken orally every 3 hours, to a maximum of 4 doses.
The woman is kept under observation in the clinic until several hours after she aborts.
|
|
|
| 16. Can misoprostol alone be used for abortion after 9 weeks of pregnancy? |
|
Misoprostol alone is sometimes used for medical abortion in pregnancies above 9 weeks duration in places where mifepristone is not available, but there is not yet enough information on the safest and most effective regimen.
Caution is needed in the use of misoprostol alone for pregnancies above 9 weeks. The dosages of misoprostol must be reduced as the duration of pregnancy increases because the uterus becomes very sensitive to prostaglandin. There is a risk of rupture of the uterus, especially after 16 weeks of pregnancy and in women who have a scar from a previous caesarean section [2].
|
|
| 17. How efficacious is medical abortion? |
|
Efficacy of medical abortion may be measured by rates of ongoing pregnancy. In pregnancies up to 9 weeks, only about 1% of women who use the mifepristone/vaginal misoprostol regimen for medical abortion have a continuing pregnancy, and in about 3-5%, abortion is incomplete [18]. Rates of complete abortion are lower when the mifepristone/oral misoprostol (400 microgram) regimen is used in pregnancies of up to 7 weeks. In one study the complete abortion rate was 84 % when mifepristone was followed by 400 micrograms of oral misoprostol, as compared to 96% with mifepristone and 800 micrograms of vaginal misoprostol [19].
Efficacy depends on the length of pregnancy: the more advanced the pregnancy, the lower the complete abortion rate and the higher the rate of ongoing pregnancy. For example, in one large study on use of medical abortion during 9-13 weeks of pregnancy (with the dosages mentioned under Q.13), 96% of the women experienced complete abortion [20]. About 5% may have an ongoing pregnancy with medical abortion at 13-20 weeks of pregnancy [18].
The success rate with misoprostol alone is lower and more variable. Efficacy rates range from 10–15% ongoing pregnancies for pregnancies up to 9 weeks duration [21]. Evidence is not yet unavailable on efficacy rates for pregnancies above 9 weeks duration.
|
|
| 18. How long does it take to terminate a pregnancy with medical abortion? |
|
When a mifepristone/misoprostol regimen is used for medical abortion in pregnancy up to 9 weeks, in a few instances (2-3% of women), a woman may abort after taking the mifepristone and before using misoprostol. Of the rest, about 90% will have a complete abortion within 4-6 hours of using misoprostol [5].
After nine weeks of pregnancy, the more advanced the pregnancy, the longer it takes to have a complete abortion [18] [20]. In one study, the time taken for complete abortion was about six hours for women with previous deliveries and about 8 hours for women with no previous deliveries. More than 70% of the women went home the same day [22].
There is a lot of variability in the reported time needed for abortion with misoprostol alone up to 9 weeks of pregnancy, depending on the duration of pregnancy, dosage and route of administration. One study reported that 72% and 86% of women aborted within 24 hours of one and two doses respectively of 800 micrograms of vaginal misoprostol [23].
|
|
| 19. How many clinic visits are required for a medical abortion? What is done during each visit? |
|
Studies show that two clinic visits are adequate to ensure safe use of mifepristone/misoprostol for pregnancies up to 9 weeks, and three clinic visits are needed for pregnancies of more than 9 weeks’ duration.
When mifepristone/misoprostol combination is used
Up to 9 weeks of pregnancy
First visit
The health provider
- counsels the woman
- takes medical history to ensure that she does not suffer from any of the medical conditions that would make medical abortion inappropriate for her
- asks the woman when the first day of her last period was and performs a pelvic exam to determine or confirm duration of pregnancy and absence of genital infection (if infection is present, it is treated)
- may perform an ultrasound if duration of pregnancy cannot be accurately assessed through medical history and pelvic exam
- gives her mifepristone to be taken orally
- gives her the choice of either taking misoprostol at home, or coming back to the clinic for taking misoprostol under medical supervision.
If the woman opts to take the misoprostol at home, then the provider
- gives her
the 800 microgram dose of misoprostol (4 pills of 200 micrograms each) to be inserted vaginally, or 400 microgram dose of misoprostol (2 pills of 200 micrograms each) to be taken orally at home, 24-48 hours after mifepristone.
- gives a pain-killer to help cope with the cramps and pain that the woman will experience once she has taken misoprostol.
Second visit (if the woman opts to take misoprostol in the clinic)
This visit should be between 24 and 48 hours after the first visit [4]. During this visit, misoprostol is inserted vaginally (in pregnancies up to nine weeks) or taken orally (in pregnancies up to seven weeks).
In many settings, the woman is kept under observation in the clinic for 4-6 hours. During this time, more than 90 per cent of women will have expelled the products of conception [5].
If abortion does not occur within the observation period, the woman may be permitted to go home to abort.
In a few places, misoprostol may be administered by a provider and the woman can leave immediately. In this case, the woman needs to know that abortion may occur before she reaches home.
Follow-up visit
All women are asked to return 14 days after they took mifepristone. This is to check if abortion is complete and that all products of conception have been expelled.
During this visit, the health provider:
- carries out a physical examination to confirm that the pregnancy has been terminated
- if in doubt after the physical exam, performs a pregnancy test or an ultrasound exam to confirm termination of pregnancy
- if abortion is not complete, either asks the woman to come back after a few more days, as the abortion may be complete by then, or administers further misoprostol, or performs a surgical procedure to complete the abortion.
Pregnancies of more than 9 weeks duration
In this case, the only difference is that there are at least three clinic visits. The woman returns to the clinic24-48 hours days after her first visit, when she took mifepristone. Misoprostol is administered by a health provider in a clinic setting.
During this visit, misoprostol is inserted vaginally, followed by several additional doses of the drug vaginally and/or orally until abortion takes place. The woman is kept under observation until several hours after she expels the products of conception.
This is followed by a follow-up visit, as described above.
When misoprostol alone is used
In pregnancies of less than 9 weeks duration, the dosage regimen consists of repeated doses of vaginal or sublingually misoprostol till abortion occurs. This may mean staying in the health facility for at least a day, or administering repeat doses of misoprostol at home, depending on the setting.
|