Expulsion at home for early medical abortion: A systematic review with meta-analyses.

The safety and acceptability of medical abortion using mifepristone and misoprostol at home at ≤9+0  weeks' gestation is well established. However, the upper gestational limit at which the procedure remains safe and acceptable at home is not known. To inform a national guideline on abortion care we conducted a systematic review to determine what gestational limit for expulsion at home offers the best balance of benefits and harms for women who are having medical abortion. We searched Embase, MEDLINE, Cochrane Library, Cinahl Plus and Web-of-Science on 2 January 2020 for prospective and retrospective cohort studies with ≥50 women per gestational age group, published in English from 1995 onwards, that included women undergoing medical abortion and compared home expulsion of pregnancies of ≤9+0  weeks' gestational age with pregnancies of 9+1 -10+0  weeks or >10+1  weeks' gestational age, or compared the latter two gestational age groups. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were meta-analyzed as risk ratios (RR) using the Mantel-Haenszel method. The certainty of the evidence was assessed using GRADE. Six studies (n = 3381) were included. The "need for emergency care/admission to hospital" (RR = 0.79, 95% confidence interval [CI] 0.45-1.4), "hemorrhage requiring transfusion/≥500 mL blood loss" (RR = 0.62, 95% CI 0.11-3.55), patient satisfaction (RR = 0.99, 95% CI 0.95-1.03), pain (RR = 0.91, 95% CI 0.82-1.02), and "complete abortion without the need for surgical intervention" (RR = 1.03, 95% CI 1-1.05) did not differ statistically significantly between the ≤9+0 and >9+0  weeks' gestation groups. The rates of vomiting (RR = 0.8, 95% CI 0.69-0.93) and diarrhea (RR = 0.85, 95% CI 0.73-0.99) were statistically significantly lower in the ≤9+0  weeks group but these differences were not considered clinically important. We found no studies comparing pregnancies of 9+1 -10+0  weeks' gestation with pregnancies of >10+0  weeks' gestation. The certainty of this evidence was predominantly low and mainly compromised by low event rates and loss to follow up. Women who are having a medical abortion and will be taking mifepristone up to and including 10+0  weeks' gestation should be offered the option of expulsion at home after they have taken the misoprostol. Further research needs to determine whether the gestational limit for home expulsion can be extended beyond 10+0  weeks.

Schmidt-Hansen M ，Pandey A ，Lohr PA ，Nevill M ，Taylor P ，Hasler E ，Cameron S ... -  《-》

Self-administered versus provider-administered medical abortion.

The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by misoprostol or a misoprostol-only regimen. The drugs are commonly administered in the presence of clinicians, which is known as provider-administered medical abortion. In self-administered medical abortion, drugs are administered by the woman herself without the supervision of a healthcare provider during at least one stage of the drug protocol. Self-administration of medical abortion has the potential to provide women with control over the abortion process. In settings where there is a shortage of healthcare providers, self-administration may reduce the burden on the health system. However, it remains unclear whether self-administration of medical abortion is effective and safe. It is important to understand whether women can safely and effectively terminate their own pregnancies when having access to accurate and adequate information, high-quality drugs, and facility-based care in case of complications. To compare the effectiveness, safety, and acceptability of self-administered versus provider-administered medical abortion in any setting. We searched Cochrane Central Register of Controlled Trials, MEDLINE in process and other non-indexed citations, Embase, CINAHL, POPLINE, LILACS, ClinicalTrials.gov, WHO ICTRP, and Google Scholar from inception to 10 July 2019. We included randomized controlled trials (RCTs) and prospective cohort studies with a concurrent comparison group, using study designs that compared medical abortion by self-administered versus provider-administered methods. Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using Review Manager 5. Our primary outcome was successful abortion (effectiveness), defined as complete uterine evacuation without the need for surgical intervention. Ongoing pregnancy (the presence of an intact gestational sac) was our secondary outcome measuring success or effectiveness. We assessed statistical heterogeneity with Chi2 tests and I2 statistics using a cut-off point of P < 0.10 to indicate statistical heterogeneity. Quality assessment of the data used the GRADE approach. We used standard methodological procedures expected by Cochrane. We identified 18 studies (two RCTs and 16 non-randomized studies (NRSs)) comprising 11,043 women undergoing early medical abortion (≤ 9 weeks gestation) in 10 countries. Sixteen studies took place in low-to-middle income resource settings and two studies were in high-resource settings. One NRS study received analgesics from a pharmaceutical company. Five NRSs and one RCT did not report on funding; nine NRSs received all or partial funding from an anonymous donor. Five NRSs and one RCT received funding from government agencies, private foundations, or non-profit bodies. The intervention in the evidence is predominantly from women taking mifepristone in the presence of a healthcare provider, and subsequently taking misoprostol without healthcare provider supervision (e.g. at home). There is no evidence of a difference in rates of successful abortions between self-administered and provider-administered groups: for two RCTs, risk ratio (RR) 0.99, 95% confidence interval (CI) 0.97 to 1.01; 919 participants; moderate certainty of evidence. There is very low certainty of evidence from 16 NRSs: RR 0.99, 95% CI 0.97 to 1.01; 10,124 participants. For the outcome of ongoing pregnancy there may be little or no difference between the two groups: for one RCT: RR 1.69, 95% CI 0.41 to 7.02; 735 participants; low certainty of evidence; and very low certainty evidence for 11 NRSs: RR 1.28, 95% CI 0.65 to 2.49; 6691 participants. We are uncertain whether there are any differences in complications requiring surgical intervention, since we found no RCTs and evidence from three NRSs was of very low certainty: for three NRSs: RR 2.14, 95% CI 0.80 to 5.71; 2452 participants. This review shows that self-administering the second stage of early medical abortion procedures is as effective as provider-administered procedures for the outcome of abortion success. There may be no difference for the outcome of ongoing pregnancy, although the evidence for this is uncertain for this outcome. There is very low-certainty evidence for the risk of complications requiring surgical intervention. Data are limited by the scarcity of high-quality research study designs and the presence of risks of bias. This review provides insufficient evidence to determine the safety of self-administration when compared with administering medication in the presence of healthcare provider supervision. Future research should investigate the effectiveness and safety of self-administered medical abortion in the absence of healthcare provider supervision through the entirety of the medical abortion protocol (e.g. during administration of mifepristone or as part of a misoprostol-only regimen) and at later gestational ages (i.e. more than nine weeks). In the absence of any supervision from medical personnel, research is needed to understand how best to inform and support women who choose to self-administer, including when to seek clinical care.

Gambir K ，Kim C ，Necastro KA ，Ganatra B ，Ngo TD ... -  《Cochrane Database of Systematic Reviews》

Simultaneous compared to interval administration of mifepristone and misoprostol for medical abortion up to 10(+0) weeks' gestation: a systematic review with meta-analyses.

Medical abortion with mifepristone and misoprostol usually involves an interval of 36-48 hours between administering these drugs; however, it is possible that the clinical efficacy at early gestations may be maintained when the drugs are taken simultaneously. The objective of this systematic review was to determine the safety and effectiveness of simultaneous compared with interval administration of mifepristone and misoprostol for abortion up to 10+0 weeks' gestation. We searched Embase Classic, Embase; Ovid MEDLINE(R) including Daily, and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations; and Cochrane Library on 11 December 2019. We included randomised controlled trials (RCTs), published in English from 1985, comparing simultaneous to interval administration of mifepristone and misoprostol for early abortion. Risk of bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs) using the Mantel-Haenszel method were performed. The quality of the evidence was assessed using GRADE. Meta-analyses of three RCTs (n=1280) showed no differences in 'ongoing pregnancy' (RR 1.78, 95% CI 0.38 to 8.36), 'haemorrhage requiring transfusion or ≥500 mL blood loss' (RR 0.11, 95% CI 0.01 to 2.03) and 'incomplete abortion with the need for surgical intervention' (RR 1.30, 95% CI 0.76 to 2.25) between the interventions. Individual study results showed no difference in patient satisfaction, or 'need for repeat misoprostol', although 'time to onset of bleeding or cramping' was longer after simultaneous than interval administration. The quality of evidence was very low to moderate. The published data support the use of simultaneous mifepristone and misoprostol for medical abortion up to 9+0 weeks in women who prefer this method of administration.

Schmidt-Hansen M ，Lord J ，Hasler E ，Cameron S ... -  《-》

Follow-up strategies to confirm the success of medical abortion of pregnancies up to 10 weeks' gestation: a systematic review with meta-analyses.

To compare the effectiveness, safety, and acceptability of in-clinic and remote/self-assessment, as well as different remote/self-assessments, for confirming the success of medical abortion at ≤10+0 weeks' gestation. Ovid Embase Classic and Embase; Ovid MEDLINE(R) and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations and Daily; and the Cochrane Library. We also consulted experts in this field for any ongoing or missed trials. Randomized controlled trials published in English from 2000 onward, comparing in-clinic assessment with ultrasound to remote or self-assessment or comparing different remote or self-assessment strategies to confirm the success of medical abortion of pregnancies up to and including 10+0 weeks gestation, reporting any of the following outcomes: "missed ongoing pregnancy," "correct implementation of the follow-up strategy," patient satisfaction/preference, "adherence to follow-up strategy," "unscheduled visits/telephone calls to the abortion service," and surgical intervention. One author assessed the risk of bias in the studies using the Cochrane Collaboration checklist for randomized controlled trials. All outcomes were analyzed as risk ratios and meta-analysed in Review Manager 5.3 using the Mantel-Haenszel statistical method and a fixed effect model. The overall quality of the evidence was assessed using GRADE. Four randomized controlled trials (n = 5761) compared in-clinic to remote self-assessment and found no clinically significant differences apart from higher preference rates for remote follow-up, especially in the remote follow-up groups. The quality of this evidence was compromised by attrition, no blinding, inconsistency, indirectness, and low event rates. Two randomized controlled trials (n = 1125) compared different remote assessment strategies (using urine pregnancy tests) and also found no clinically significant differences apart from a clinically significantly lower rate of unscheduled visits to the abortion service in the remote follow-up group using a multilevel urine pregnancy test compared to remote follow-up using a high-sensitivity urine pregnancy test. The quality of this evidence was compromised by small event rates, lack of blinding, indirectness and high attrition rates. The published data support offering women who have had a medical abortion up to and including 10+0 weeks' gestation the choice of self-assessment, remote assessment, or clinic follow-up.

Schmidt-Hansen M ，Cameron S ，Lohr PA ，Hasler E ... -  《-》

Medical methods for first trimester abortion.

Kulier R ，Gülmezoglu AM ，Hofmeyr GJ ，Cheng LN ，Campana A ... -  《Cochrane Database of Systematic Reviews》