Medical abortion

Not to be confused with Emergency birth control.
Medical abortion
United States 1979 (carboprost),
West Germany 1981 (sulprostone),
Japan 1984 (gemeprost),
France 1988 (mifepristone),
United States 1988 (misoprostol)
3–24+ weeks
Background
Last use96% (2021)
Gestation87% (2021)
99% (2021)
Usage
Medical abortions as a percentage of all abortions
Infobox references
Mifepristone/misoprostol
Combination of
MifepristoneProgesterone receptor modulator
MisoprostolProstaglandin
Names
Trade namesMifegymiso,[1] Medabon Combipack
Clinical data
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Legal
Legal status

Medical abortion, also known as medication abortion, is when medication are used to bring about an abortion. They are an alternative to surgical abortions such as vacuum aspiration or dilation and curettage.[5] They are more common than surgical abortions in most places, including Europe, India, China, and the United States.[6][7]

They are typically performed by administering a two-drug combination: mifepristone followed by misoprostol. When mifepristone is not available, misoprostol alone may be used.[8] The medication can be safely taken at home, without assistance, in the first trimester.[9] Starting with the second trimester, it is recommended to take the second drug in a clinic or provider's office.[9]

Medical abortion is both safe and effective throughout a range of gestational ages, including the second and third trimester.[10] In the United States, deaths of the mother is 14 times lower than the rate in childbirth, and serious complications requiring hospitalization or blood transfusion is less than 4 in a 1,000.[11][12][13][14]

Medical abortion should not be confused with emergency contraception, which involves medication (such as Levonorgestrel or "Plan B") taken soon after sex to prevent a pregnancy from beginning.

Medications

Less than 12 weeks' gestation

For medical abortion up to 12 weeks' gestation, the recommended drug dosages are 200 milligrams of mifepristone by mouth, followed one to two days later by 800 micrograms of misoprostol inside the cheek, vaginally, or under the tongue.[15] The success rate of this drug combination is 96.6% through 10 weeks' pregnancy.[16]

Misoprostol should be administered 24 to 48 hours after the mifepristone; taking the misoprostol before 24 hours have elapsed reduces the probability of success.[13] However, one study showed that the two drugs may be taken simultaneously with nearly the same efficacy.[17]

For pregnancies after 9 weeks, two doses of misoprostol (the second drug) makes the treatment more effective.[18] From 10 to 11 weeks of pregnancy, the National Abortion Federation suggests second dose of misoprostol (800 micrograms) four hours after the first dose.[19]

After the patient takes mifepristone, they must also administer the misoprostol. Failure to take the misoprostol may result in any of these outcomes: the fetus may be terminated, but not fully expelled from the uterus (possibly accompanied by hemorrhaging) and may require surgical intervention to remove the fetus; or the pregnancy may be successfully aborted and expelled; or the pregnancy may continue with a healthy fetus. For those reasons, misoprostol should always be taken after the mifepristone.[20]

If the pregnancy involves twins, a higher dosage of mifepristone may be recommended.[21]

Self-administered medical abortion

In the first trimester, self-administered medical abortion is available for patients who prefer to take the abortion drugs at home without direct medical supervision (in contrast to provider-administered medical abortion where the patient takes the second abortion drug in the presence of a trained healthcare provider).[9] Evidence from clinical trials indicates self-administered medical abortion is as effective as provider-administered abortion; however additional research is required to confirm that safety is equivalent.[22][23]

The procedure used to administer the two drugs depends on specific drugs prescribed. A typical procedure, for 200 mg mifepristone tablets, is:[24][25][26]

  1. Take the mifepristone
  2. Take the misoprostol between 24 hours and 48 hours after the mifepristone
  3. The pregnancy (embryo and placenta) will be expelled through the vagina within 2 to 24 hours after taking misoprostol, so the patient should remain near toilet facilities at that time. Cramps, nausea and bleeding may be experienced while the pregnancy is being expelled, and afterwards
  4. To avoid infection, the patient should not use tampons or engage in intercourse for 2 to 3 weeks[27]
  5. The patient should contact their provider 7 to 14 days after the administration of mifepristone to confirm that complete termination of pregnancy has occurred and to evaluate the degree of bleeding

After 12 weeks' gestation

Medical abortion is safe and effective in the second and third trimesters.[10][28][29][30] The WHO recommends that medical abortions performed after 12 weeks' gestation be supervised by a generalist medical practitioner or specialist medical practitioner (in contrast to first trimester, where the patient may safely take the drugs at home without supervision).[9][15]

For medical abortion after 12 weeks' gestation, the WHO recommends 200 mg of mifepristone by mouth followed one to two days later by repeat doses of 400 μg misoprostol under the tongue, inside the cheek, or in the vagina.[15] Misoprostol should be taken every 3 hours until successful abortion is achieved, the mean time to abortion after starting misoprostol is 6–8 hours, and approximately 94% will abort within 24 hours after starting misoprostol.[31] When mifepristone is not available, misoprostol may still be used though the mean time to abortion after starting misoprostol will be extended compared to regimens using mifepristone followed by misoprostol.[32]

Alternative medications

The mifepristone/misoprostol combination is, by far, the most recommended regimen for medical abortions, but other options are available.

Misoprostol alone, without mifepristone, may be used in some circumstances for medical abortion, and has been demonstrated to be successful in the second trimester. Misoprostol is more commonly available than mifepristone, and is easier to store and administer, so misoprostol without mifepristone may be suggested by the provider if mifepristone is not available.[8] If misoprostol is used without mifepristone, the WHO recommends 800 μg of misoprostol inside the cheek, under the tongue, or in the vagina.[15] The success rate of misoprostol alone for terminating pregnancy (93%) is nearly the same as the mifepristone-misoprostol combination (96%). However, 15% of the women using misoprostol alone required a surgical follow-up procedure, which is more than with the mifepristone-misoprostol combination.[33]

A rarely used drug combination is methotrexate-misoprostol, which is typically reserved for ectopic pregnancies.[34] Methotrexate is given either by mouth or by injection into a muscle, followed by vaginal misoprostol 3–5 days later.[19] The methotrexate combination is available through 63 days. The WHO authorizes the methotrexate-misoprostol combination[35] but recommends the mifepristone combination because methotrexate may cause birth defects in cases of incomplete abortion. The methotrexate-misoprostol combination is considered more effective than misoprostol alone.[36]

Contraindications

Contraindications to mifepristone are inherited porphyria, chronic adrenal failure, and ectopic pregnancy.[37][38] Some consider an intrauterine device in place to be a contraindication as well.[38] A previous allergic reaction to mifepristone or misoprostol is also a contraindication.[37]

Many studies excluded women with severe medical problems such as heart and liver disease or severe anemia.[38] Caution is required in a range of circumstances including:[37]

In some cases, it may be appropriate to refer people with preexisting medical conditions to a hospital-based abortion provider.[39]

Side effects

Most women will have cramping and bleeding heavier than a menstrual period.[38] Other adverse effects include nausea, vomiting, fever, chills, diarrhea, and headache.[27] Misoprostol taken vaginally tends to have fewer gastrointestinal side effects. Nonsteroidal antiinflammatory medications such as ibuprofen reduce pain with medication abortion.

Complications

Symptoms that require immediate medical attention:[40]

  • Heavy bleeding (enough blood to soak through four sanitary pads in 2 hours)
  • Abdominal pain, nausea, vomiting, diarrhea, fever for more than 24 hours after taking mifepristone
  • Fever of 38 °C (100.4 °F) or higher for more than 4 hours

Complications under 10 weeks' pregnancy are rare; according to two large reviews, bleeding requiring a blood transfusion occurred in 0.03–0.6% of women and serious infection in 0.01–0.5%.[16][13] Because infection is rare after medication abortion, the American College of Obstetricians and Gynecologists, The Society of Family Planning, and the NAF do not recommend use of routine antibiotics.[41][19] A few rare cases of deaths from clostridial toxic shock syndrome have occurred following medical abortions.[42]

A 2013 systematic review which included 45,000 women who used the 200 mg mifeprestone followed by misoprostol combination found that less than 0.4% had serious complications requiring hospitalization (0.3%) and/or blood transfusion (0.1%).[13][14]

Management of bleeding

Vaginal bleeding generally diminishes gradually over about two weeks after a medical abortion, but in individual cases spotting can last up to 45 days.[37] If the woman is well, neither prolonged bleeding nor the presence of tissue in the uterus (as detected by obstetric ultrasonography) is an indication for surgical intervention (that is, vacuum aspiration or dilation and curettage). Remaining products of conception will be expelled during subsequent vaginal bleeding. Still, surgical intervention may be carried out on the woman's request, if the bleeding is heavy or prolonged, or causes anemia, or if there is evidence of endometritis.

Although medical abortion is associated with more bleeding than surgical abortion, overall bleeding for the two methods is minimal and not clinically different. In a large-scale prospective trial published in 1992 of more than 16,000 women undergoing medical abortion using mifepristone with varying doses of gemeprost or sulprostone, only 0.1% had hemorrhage requiring a blood transfusion. It is often advised to contact a health care provider if there is bleeding to such degree that more than two pads are soaked per hour for two consecutive hours.

Safety

Medical abortion is safe even into the second and third trimesters.[10][28][29][30]

In the United States, an FDA report states that of the 3.7 million women who have had a medication abortion between 2000 and 2018, 24 died afterward, with 11 of those deaths likely unrelated to the abortion, including drug overdoses, homicides, and a suicide.[11][12] If the deaths likely unrelated to the abortion are not included, then the mortality rate for medication abortion is half the mortality rate of abortion overall.[11]:1 Including all 24 deaths, the data shows that (in the US) the mortality rate for medication abortion is equivalent to abortion overall, which is 14 times lower than the mortality rate for childbirth, and also lower than the mortality rate for Penicillin and Viagra.[11][12]

Pharmacology

Main article: Mifepristone § Pharmacology

Mifepristone blocks the hormone progesterone,[43][44] causing the lining of the uterus to thin and preventing the embryo from staying implanted and growing. Methotrexate, which is sometimes used instead of mifepristone, stops the cytotrophoblastic tissue from growing and becoming a functional placenta.[45] Misoprostol, a synthetic prostaglandin, causes the uterus to contract and expel the embryo through the vagina.[46]

Prevalence

Medical abortions as a percentage of all abortions
CountryPercentage
Spain25% in 2021[47]
Netherlands34% in 2021[48]
Italy35% in 2020[49]
Canada37% in 2021[50]
Belgium38% in 2021[51]
Germany39% in 2022[52]
New Zealand46% in 2021[53]
United States53% in 2020[7]
Portugal68% in 2021[54]
Slovenia72% in 2019[55]
France76% in 2021[56]
Switzerland80% in 2021[57]
Denmark83% in 2021[58]
England and Wales87% in 2021[59]
Iceland87% in 2021[60]
Estonia91% in 2021[61]
Norway95% in 2022[62]
Sweden96% in 2021[63]
Finland98% in 2021[64]
Scotland99% in 2021[65]

A Guttmacher Institute survey of all known abortion providers in the U.S. found that medical abortions accounted for 53% of all abortions in 2020.[7] This count did not include self-induced abortions.[7]

At Planned Parenthood clinics in the U.S., medical abortions accounted for 32% of first trimester abortions in 2008,[66] 35% of all abortions in 2010 and 43% of all abortions in 2014.[67]

In 2009, medical abortion regimens using mifepristone in combination with a prostaglandin analog were the most common methods used to induce second-trimester abortions in Canada, most of Europe, China and India;[6] in contrast to the U.S., where 96% of second-trimester abortions were performed surgically by dilation and evacuation.[68]

History

Swedish researchers began testing potential abortifacients in 1965. In 1968, the Swedish physician Lars Engström published a paper on a clinical trial, conducted at the women's clinic of Karolinska Hospital in Stockholm, of the compound F6103 on pregnant Swedish women with the aim of inducing abortion. It was the first clinical trial of an abortion pill to be conducted in Sweden.[69] The paper, originally titled The Swedish Abortion Pill, was renamed to The Swedish Postconception Pill, due to the small number of induced abortions that occurred in the trial population. After these efforts were largely unsuccessful with F6103, the same researchers attempted to find an abortion pill with prostaglandins, capitalizing on the number of well-established prostaglandin scientists working in Sweden at the time; they were eventually awarded the 1982 Nobel Prize in Physiology for their work.[70]

Medical abortion became a successful alternative method of abortion with the availability of prostaglandin analogs in the 1970s and the antiprogestogen mifepristone (also known as RU-486)[71] in the 1980s.[6][36][72] Mifepristone was first approved for use in China and France in 1988, in Great Britain in 1991, in Sweden in 1992, in Austria, Belgium, Denmark, Finland, Georgia, Germany, Greece, Iceland, Israel, Lichtenstein, Luxembourg, Netherlands, Russia, Spain, and Switzerland in 1999, in Norway, Taiwan, Tunisia, and the United States in 2000, and in 70 additional countries from 2001 to 2023.[73]

In 2000, mifepristone was approved by the U.S. FDA for abortions through 49 days gestation.[74] In 2016, the U.S. FDA updated mifepristone's label to support usage through 70 days gestation.[75]

Society and culture

The WHO affirms that laws and policies should support people's access to evidence-based medically approved care, including medical abortion.[76][77]

Accessibility

Both medication – mifepristone and misoprostol – are no longer covered by drug patents, and hence are available as generic drugs.

Over-the-counter

The requirements for a prescription vary widely between countries.[78] Many countries make the medical abortion drugs available over the counter, without a prescription, such as China, India, and others.[79] Other countries require a prescription (Canada, most of Western Europe, the United States, and others).[79] Some countries require a prescription but are lax about enforcing that requirement (Russia, Brazil, and others).[79]

Telehealth

Telehealth includes access to medical services that the person can perform at home, without in-person visits to clinic or provider offices. People who have used telehealth report being satisfied with the access it provides to abortion services.[80][81] However, those who might need the service the most (those who are incarcerated, unhoused, or live on low income) are often inhibited from accessing it.[82]

Telehealth options for people in the U.S. seeking medical abortion include: Aid Access, Plan C, Hey Jane, Choix, Just the Pill, carafem, and Abortion on Demand.[83]

Clinic-to-clinic access

In this model, a provider communicates with a patient located at another site using clinic-to-clinic videoconferencing to provide medication abortion. This was introduced by Planned Parenthood of the Heartland in Iowa to allow a patient at one health facility to communicate via secure video with a health provider at another facility.[84] This model has expanded to other Planned Parenthoods in multiple states as well other clinics providing abortion care.[84]

Direct-to-patient access

The direct-to-patient model allows for medication abortion to be provided without an in-person clinic visit. Instead of an in-person clinic visit, the patient receives counseling and instruction from the abortion provider via videoconference. The patient can be at any location, including their home. The medications necessary for the abortion are mailed directly to the patient. This is a model, called TelAbortion or no-test medication abortion (formerly no-touch medication abortion), being piloted and studied by Gynuity Health Projects, with special approval from the U.S. Food and Drug Administration (FDA).[85] This model has been shown to be safe, effective, efficient, and satisfactory.[86][87][88] Complete abortion can be confirmed via telephone-based assessment.[89]

United States

Further information: Abortion in the United States by state

In the U.S., prescriptions for mifepristone may be filled by any pharmacy - online or brick-and-mortar - that has obtained a special certification.[90] This regulation was provisionally implemented in Dec 2021, and was finalized by the FDA in January 2023.[91]

From 2011 until 2021, a patient was required to visit a healthcare provider in-person (at a clinic or office) and receive mifepristone directly from the provider.[92] The requirement to visit a clinic to receive the drug was removed by the FDA in December 2021, during the COVID-19 pandemic. Under the new rules, the prescription may be obtained via telehealth (phone calls or video conferencing with a healthcare provider), and then filled at any certified pharmacy.[93][26][86][94] At the same time the FDA removed the requirement for an in-person visit, they added a requirement that dispensing pharmacies be "certified", which requires the pharmacy to have special permission to dispense the drugs – a requirement the FDA imposes on only 40 drugs out of more than 19,000 it manages.[95]

The second drug used in medical abortion, misoprostol, is most commonly used for treating ulcers, and was never subject to the in-person dispensing constraints of mifepristone, and was always available from pharmacies with a prescription.

The FDA does not authorize the use of mifepristone for medical abortion after 70 days, unlike most other countries, which authorize medical abortion into the second trimester and even the third trimester.[93]

Some states have passed laws that prohibit providers from examining the patient via phone or video conferencing, and instead require the patient to make an in-person visit to the provider to get the prescription.[96][97]

In most states, abortion drugs may be sent from a pharmacy to the patient via mail, but certain states have passed laws making that illegal, and requiring the drugs to be obtained from a pharmacy or provider in-person.[96][98]

Interest in abortion medications in the United States reached record highs in 2022, after the Supreme Court of the United States draft Dobbs v. Jackson Women's Health Organization ruling that would overturn 1973's Roe v. Wade decision was leaked online.[99] Interest was higher in states with more restrictions on access to abortion.[99] Pro-choice activists in the U.S. were exploring ways to make medical abortion more available, particularly in states where it is subject to limitations, with social media resources being utilized for this purpose.[100][101][102][103]

In March 2023, Governor Mark Gordon of Wyoming signed a bill outlawing the use of abortion pills in the state, making it the first US state to do so. The new legislation, which will go into effect on July 1, 2023, criminalizes the "prescription, dispensation, distribution, sale, or use of any drug" for the purpose of obtaining or performing an abortion. Those who violate the law, excluding the pregnant individual, may be charged with a misdemeanor and could face a $9,000 fine and up to six months in jail. Abortion providers are expected to challenge the new law in court.[104]

"Reversal" controversy

Some anti-abortion groups claim that patients who change their mind about the abortion after taking mifepristone can "reverse" the abortion by administering progesterone (and not administering misoprostol).[105][106] As of 2022, there is no scientifically rigorous evidence that the effects of mifepristone can be reversed this way.[107][108] Even so, several states in the U.S. require providers of non-surgical abortion who use mifepristone to tell patients that reversal is an option.[109] In 2019, researchers initiated a small trial of the so-called "reversal" regimen using mifepristone followed by progesterone or placebo.[110][111] The study was halted after 12 women enrolled and three experienced severe vaginal bleeding. The results raise serious safety concerns about using mifepristone without follow-up misoprostol.[108]

Cost

In the U.S. in 2009, the typical price charged for a medical abortion up to 9 weeks' gestation was $490, four percent higher than the $470 typical price charged for a surgical abortion at 10 weeks' gestation.[112] In the U.S. in 2008, 57% of women who had abortions paid for them out of pocket.[113]

In April 2013, the Australian government commenced an evaluation process to decide whether to list mifepristone (RU486) and misoprostol on the country's Pharmaceutical Benefits Scheme (PBS). If the listing is approved by the Health Minister Tanya Plibersek and the federal government, the drugs will become more accessible due to a dramatic reduction in retail price—the cost would be reduced from between AU$300 and AU$800, to AU$12 (subsidised rate for concession card holders) or AU$35.[114] On 30 June 2013, the Australian Minister for Health, the Hon. Tanya Plibersek MP, announced that the Australian Government had approved the listing of mifepristone and misoprostol on the PBS for medical termination in early pregnancy consistent with the recommendation of the Pharmaceutical Benefits Advisory Committee.[115] These listings on the PBS commenced on 1 August 2013.[116][117]

References

  1. ↑ Linepharma International Limited (15 April 2019). "Mifegymiso Product Monograph" (PDF). Health Canada. Archived (PDF) from the original on 22 March 2023. Retrieved 18 August 2023.
  2. ↑ "Medabon - Combipack of Mifepristone 200 mg tablet and Misoprostol 4 x 0.2 mg vaginal tablets - Summary of Product Characteristics (SmPC)". Electronic Medicines Compendium (EMC). 3 February 2020. Archived from the original on 9 June 2021. Retrieved 19 January 2021.
  3. ↑ "The Abortion Pill | Get the Facts About Medication Abortion". Planned Parenthood. Archived from the original on 2023-08-16. Retrieved 2023-08-18.
  4. ↑ "Mifepristone/misoprostol: List of nationally authorised medicinal products" (PDF). European Medicines Agency. 14 January 2021. PSUSA/00010378/202005. Archived (PDF) from the original on 16 September 2023. Retrieved 18 August 2023.
  5. ↑ Zhang J, Zhou K, Shan D, Luo X (May 2022). "Medical methods for first trimester abortion". The Cochrane Database of Systematic Reviews. 2022 (5): CD002855. doi:10.1002/14651858.CD002855.pub5. PMC 9128719. PMID 35608608.
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  19. 1 2 3 "NAF Clinical Policy Guidelines". National Abortion Federation. Archived from the original on 2022-08-08. Retrieved 2020-04-10.
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  21. ↑ Sørensen EC, Iversen OE, Bjørge L (March 2005). "Failed medical termination of twin pregnancy with mifepristone: a case report". Contraception. 71 (3): 231–233. doi:10.1016/j.contraception.2004.09.002. PMID 15722075.
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  24. ↑ "MIFEPREX (mifepristone) Tablets Label". FDA. Archived from the original on 2022-07-29. Retrieved 2022-06-30.
  25. ↑ "Mifepristone and misoprostol: Recommended regimen". Ipas. January 30, 2020. Archived from the original on 2022-07-14. Retrieved 2022-06-30.
  26. 1 2 "Mifeprex (mifepristone) Information". FDA. 2022-02-07. Archived from the original on 2019-04-23. Retrieved 2023-08-18.
  27. 1 2 "Medical Abortion: What Is It, Types, Risks & Recovery". Cleveland Clinic. 2021-10-21. Archived from the original on 2022-06-28. Retrieved 2022-06-30.
  28. 1 2 Safe abortion: technical and policy guidance for health systems-2nd ed. Italy: WHO. 2012. p. 42. ISBN 9789241548434.
  29. 1 2 Gómez Ponce de León R, Wing DA (April 2009). "Misoprostol for termination of pregnancy with intrauterine fetal demise in the second and third trimester of pregnancy - a systematic review". Contraception. 79 (4): 259–71. doi:10.1016/j.contraception.2008.10.009. PMID 19272495.
  30. 1 2 Mendilcioglu I, Simsek M, Seker PE, Erbay O, Zorlu CG, Trak B (November 2002). "Misoprostol in second and early third trimester for termination of pregnancies with fetal anomalies". International Journal of Gynaecology and Obstetrics. 79 (2): 131–5. doi:10.1016/s0020-7292(02)00224-2. PMID 12427397. S2CID 44373757.
  31. ↑ Borgatta L, Kapp N (July 2011). "Clinical guidelines. Labor induction abortion in the second trimester". Contraception. 84 (1): 4–18. doi:10.1016/j.contraception.2011.02.005. PMID 21664506.
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