Medical termination for pregnancy in early first trimester (≤ 63 days) using combination of mifepristone and misoprostol or misoprostol alone: a systematic review

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Abstract

Background

A wide range of drugs have been studied for first trimester medical abortion. Studies evaluating different regimens, including combination mifepristone and misoprostol and misoprostol alone regimens, show varying results related to safety, efficacy and other outcomes. Thus, the objectives of this systematic review were to compare the safety, effectiveness and acceptability of medical abortion and to compare medical with surgical methods of abortion ≤63 days of gestation.

Methods

Pubmed and EMBASE were systematically searched from database inception through January 2019 using a combination of MeSH, keywords and text words.

Randomized controlled trials on induced abortion at ≤63 days that compared different regimens of medical abortion using mifepristone and/or misoprostol and trials that compared medical with surgical methods of abortion were included.

We extracted data into a pre-designed form, calculated effect estimates, and performed meta-analyses where possible. The primary outcomes were ongoing pregnancy and successful abortion.

Results

Thirty-three studies composed of 22,275 participants were included in this review. Combined regimens using mifepristone and misoprostol had lower rates of ongoing pregnancy, higher rates of successful abortion and satisfaction compared to misoprostol only regimens. In combined regimens, misoprostol 800 μg was more effective than 400 μg. There was no significant difference in dosing intervals between mifepristone and misoprostol and routes of misoprostol administration in combination or misoprostol alone regimens. The rate of serious adverse events was generally low.

Conclusion

In this systematic review, we find that medical methods of abortion utilizing combination mifepristone and misoprostol or misoprostol alone are effective, safe and acceptable. More robust studies evaluating both the different combination and misoprostol alone regimens are needed to strengthen existing evidence as well as assess patient perspectives towards a particular regimen.

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Most cited references 35

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Article: not found

Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial.

Helena von Hertzen, N N Vy, Hoang Tuyet … (2007)

The most effective route and best interval between several doses of misoprostol to induce abortion have not been defined. Our aim was to assess the effects of the interval between multiple doses of misoprostol and the route of administration to terminate pregnancy. 2066 healthy pregnant women requesting medical abortion with 63 days or less of gestation were randomly assigned within 11 gynaecological centres in six countries to the four treatment groups (three doses of 0.8 mg misoprostol given sublingually at 3-h intervals, vaginally 3 h, sublingually 12 h, and vaginally 12 h), stratifying by gestational age. This was an equivalence trial with a 5% margin of equivalence. The primary endpoints were efficacy of treatment to achieve complete abortion and to terminate pregnancy. The main efficacy analysis excluded women lost to follow-up. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN10531821. Efficacy outcomes were analysed for 2046 women (99%), excluding 20 lost to follow-up. Complete abortion rates at 2-week follow-up were recorded for 431 (84%) in the sublingual and for 434 (85%) women in the vaginal group when misoprostol was given at 3-h intervals (difference 0.4%, 95% CI -4.0 to 4.9, p=0.85 equivalence shown), and for 399 (78%) in the sublingual and for 425 (83%) in the vaginal 12-h groups (4.6%, -0.2 to 9.5, p=0.06, equivalence not shown). In the 3-h groups, pregnancy continued in 29 (6%) women after sublingual and in 20 (4%) women after vaginal administration (difference 1.8%, 95% CI -0.8 to 4.4, p=0.19, equivalence shown); in the 12-h groups it continued in 47 (9%) after sublingual and in 25 (5%) after vaginal administration (4.4%, 1.2-7.5, p=0.01, vaginal better than sublingual). Differences for complete abortion between intervals for sublingual and vaginal routes were 6% (95% CI 1.0-10.6, p=0.02, 3 h better than 12 h) and 2% (-2.9 to 6.1, p=0.49, equivalence not shown), respectively; for continuing pregnancies they were 4% (0.4-6.8, p=0.03, 3 h better than 12 h) and 1% (-1.5 to 3.5, p=0.44, equivalence shown), respectively. Administration interval can be chosen between 3 h and 12 h when misoprostol is given vaginally. If administration is sublingual, the intervals between misoprostol doses need to be short, but side-effects are then increased. With 12-h intervals, vaginal route should be used, whereas with 3-h intervals either route could be chosen.

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Article: not found

Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol.

H el-Refaey, D Rajasekar, Amani M. Abdalla … (1995)

Medical termination of pregnancy can be successfully performed with a combination of mifepristone (RU 486) and a prostaglandin analogue. We conducted a prospective, randomized trial to compare oral with vaginal administration of the prostaglandin E1 analogue misoprostol for first-trimester abortion in women treated initially with mifepristone.

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Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial.

Simon Goldberg, Anita Y. M. Howe, J Moskowitz … (2008)

To study the efficacy, safety, and acceptability of oral immediately swallowed and buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days since the last menstrual period (LMP). This seven-site study randomly assigned 966 women seeking abortions to oral or buccal misoprostol 800 mcg 24-36 hours after mifepristone 200 mg with 7-14-day follow-up. Success rates in the oral and buccal groups were 91.3% (389 of 426) and 96.2% (405 of 421), respectively (P=.003; relative risk [RR] 0.95, 95% confidence interval [CI] 0.92-0.98). Ongoing pregnancy occurred in 3.5% (15 of 426) of women who took oral misoprostol compared with 1.0% (4 of 421) of women in the buccal group (P=.012; RR 3.71, 95% CI 1.24-11.07). Through 49 days since the LMP, oral and buccal regimens performed similarly, but success with oral misoprostol decreased as pregnancy advanced. In pregnancies of 57-63 days since the LMP, success with oral misoprostol fell below 90%, whereas that with buccal remained high (oral 85.1% [97 of 114], buccal 94.8% [109 of 115], P=.015, RR 0.90, 95% CI 0.82-0.98). Furthermore, in this gestational age group, there were significantly more ongoing pregnancies among women who took misoprostol orally (7.9% [9 of 114]) compared with buccally (1.7% [2 of 115]; P=.029, RR 4.54, 95% CI 1.0-20.55). Adverse effect profiles were similar, although fever and chills were reported approximately 10% more often among women who took buccal misoprostol. Satisfaction and acceptability were high for both methods. Buccal misoprostol 800 mcg after mifepristone 200 mg is a good option for medical abortion through 63 days since the LMP. Oral misoprostol 800 mcg is also a safe and effective alternative, although success rates diminish with increasing gestational age. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386867 I.

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Author and article information

Contributors

Ferid A. Abubeker:

ORCID: http://orcid.org/0000-0002-2624-544X

ferid.abas@sphmmc.edu.et

Antonella Lavelanet: lavelaneta@who.int

Maria I. Rodriguez: rodrigma@ohsu.edu

Caron Kim: kimca@who.int

Journal

Journal ID (nlm-ta): BMC Womens Health

Journal ID (iso-abbrev): BMC Womens Health

Title: BMC Women's Health

Publisher: BioMed Central (London )

ISSN (Electronic): 1472-6874

Publication date (Electronic): 7 July 2020

Publication date PMC-release: 7 July 2020

Publication date Collection: 2020

Volume: 20

Electronic Location Identifier: 142

Affiliations

[1 ]GRID grid.3575.4, ISNI 0000000121633745, UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, ; Geneva, Switzerland

[2 ]GRID grid.5288.7, ISNI 0000 0000 9758 5690, Department of Obstetrics & Gynecology, , Oregon Health & Science University, ; Oregon, Portland USA

Author information

Ferid A. Abubeker http://orcid.org/0000-0002-2624-544X

Article

Publisher ID: 1003

DOI: 10.1186/s12905-020-01003-8

PMC ID: 7339463

PubMed ID: 32635921

SO-VID: 7f5bb474-1284-4b19-9b66-b6fda7597099

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 27 September 2019

Date accepted : 26 June 2020

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ScienceOpen disciplines: Obstetrics & Gynecology

Keywords: medical abortion,first trimester,mifepristone,misoprostol,systematic review

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ScienceOpen disciplines: Obstetrics & Gynecology

Keywords: medical abortion, first trimester, mifepristone, misoprostol, systematic review

Medical termination for pregnancy in early first trimester (≤ 63 days) using combination of mifepristone and misoprostol or misoprostol alone: a systematic review

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Most cited references 35

Efficacy of two intervals and two routes of administration of misoprostol for termination of early pregnancy: a randomised controlled equivalence trial.

Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol.

Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial.

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