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Simultaneous Compared With Interval Medical Abortion Regimens Where Home Use Is Restricted.

ABSTRACT: OBJECTIVE:To evaluate outcomes with simultaneous administration of mifepristone and misoprostol for medical abortion at 63 days of gestation or less in the year after its implementation in a British clinic system. METHODS:We conducted a retrospective cohort study using deidentified data from the electronic booking and complications databases and medical records of women who underwent medical abortion at British Pregnancy Advisory Service. Our primary outcome was treatment success with simultaneous dosing compared with a regimen with a 24- to 48-hour interval between medications. We defined success as complete abortion without surgical evacuation and without continuing pregnancy. To assess relative regimen effectiveness while accounting for self-assignment to simultaneous or interval dosing, we modeled the probability of treatment success using logistic regression with propensity score adjustment for demographic and clinical characteristics. Secondary outcomes were reasons for abortion failure and clinically significant adverse events (hospital admission, blood transfusion, intravenous antibiotic administration). RESULTS:Of 28,901 women treated between May 2015 and April 2016, 85% chose simultaneous dosing. Overall success rates were high with both regimens but lower with simultaneous than with interval dosing (94.5% vs 97.1%, respectively, adjusted relative risk 0.973, 95% CI 0.967-0.979). For both regimens, success rates were lower at higher gestational ages, but the relative effectiveness of simultaneous dosing did not vary significantly with gestational age (P=.268). Surgical intervention rates for continuing pregnancy were lowest at 49 days of gestation or less (1.4% simultaneous vs 0.2% interval, P<.001) and highest at 57-63 days of gestation (5.0% and 2.2%, P<.001). The rate of clinically significant adverse events was 0.2% and did not differ by regimen (P=.972). CONCLUSION:Simultaneous administration of mifepristone and misoprostol is 97% as effective as a 24- to 48-hour interval at all gestational ages 63 days or less with no increase in the risk of clinically significant adverse events. Pragmatic use of simultaneous dosing is reasonable given the small difference in effectiveness.

SUBMITTER: Lohr PA

PROVIDER: S-EPMC5869142 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Simultaneous Compared With Interval Medical Abortion Regimens Where Home Use Is Restricted.

Lohr Patricia A PA Starling Jennifer E JE Scott James G JG Aiken Abigail R A ARA

Obstetrics and gynecology 20180401 4

<h4>Objective</h4>To evaluate outcomes with simultaneous administration of mifepristone and misoprostol for medical abortion at 63 days of gestation or less in the year after its implementation in a British clinic system.<h4>Methods</h4>We conducted a retrospective cohort study using deidentified data from the electronic booking and complications databases and medical records of women who underwent medical abortion at British Pregnancy Advisory Service. Our primary outcome was treatment success ...[more]

PMID: 29528933

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Project description:Abortion is legally restricted in most of Latin America where 95% of the 4.4 million abortions performed annually are unsafe. Medical abortion (MA) refers to the use of a drug or a combination of drugs to terminate pregnancy. Mifepristone followed by misoprostol is the most effective and recommended regime. In settings where mifepristone is not available, misoprostol alone is used.Medical abortion has radically changed abortion practices worldwide, and particularly in legally restricted contexts. In Latin America women have been using misoprostol for self-induced home abortions for over two decades.This article summarizes the findings of a literature review on women's experiences with medical abortion in Latin American countries where voluntary abortion is illegal.Women's personal experiences with medical abortion are diverse and vary according to context, age, reproductive history, social and educational level, knowledge about medical abortion, and the physical, emotional, and social circumstances linked to the pregnancy. But most importantly, experiences are determined by whether or not women have the chance to access: 1) a medically supervised abortion in a clandestine clinic or 2) complete and accurate information on medical abortion. Other key factors are access to economic resources and emotional support.Women value the safety and effectiveness of MA as well as the privacy that it allows and the possibility of having their partner, a friend or a person of their choice nearby during the process. Women perceive MA as less painful, easier, safer, more practical, less expensive, more natural and less traumatic than other abortion methods. The fact that it is self-induced and that it avoids surgery are also pointed out as advantages. Main disadvantages identified by women are that MA is painful and takes time to complete. Other negatively evaluated aspects have to do with side effects, prolonged bleeding, the possibility that it might not be effective, and the fact that some women eventually need to seek medical care at a hospital where they might be sanctioned for having an abortion and even reported to the police.

Project description:BackgroundMifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen.ObjectivesThe objectives were to systematically review randomized controlled trials (RCTs) investigating efficacy, safety and satisfaction of medical abortion at ≥ 12 weeks' gestation.Data sourcesWe searched PubMed, Popline, Embase, Global Index Medicus, Cochrane Controlled Register of Trials and International Clinical Trials Registry Platform from January 2008 to May 2017.Study eligibility participants and interventionsWe included RCTs on medical abortion at ≥ 12 weeks' gestation using mifepristone and/or misoprostol. We excluded studies with spontaneous abortion, fetal demise and mechanical cervical ripening and those not reporting ongoing pregnancy (OP).Study appraisal and synthesis methodsAfter extracting prespecified data and assessing risk of bias in accordance with the Cochrane handbook, we used Revman5 software to combine data and GRADE to assess certainty of evidence.ResultsWe included 43 of the 1894 references identified. Combination mifepristone-misoprostol had lower rates of OP [risk ratio (RR) 0.12, 95% confidence interval (CI) 0.04-0.35] vs. misoprostol only. A 24-h interval between mifepristone and misoprostol had lower OP rate at 24 h than simultaneous dosing (RR 3.13, 95% CI 1.23-7.94). Every 3-h dosing had lower OP rate at 48 h (RR 0.39, 95% CI 0.17-0.88).LimitationsDirect comparisons of buccal misoprostol to sublingual or vaginal routes after mifepristone were limited. Evidence from clinical trials on how to best manage women with prior uterine incisions was lacking.ConclusionOur analysis supports the use of mifepristone 200 mg 1 to 2 days before misoprostol 400 mcg vaginally every 3 h at ≥ 12 weeks' gestation.ImplicationsWhere available, providers should use mifepristone plus misoprostol for second-trimester medical abortion. Vaginal misoprostol appears to be most efficacious with fewest side effects, but sublingual and buccal routes are also acceptable.

Project description:ObjectivesTo compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%.DesignRandomised controlled trial with 1:1 allocation.SettingCommunity abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK.ParticipantsThe trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation.Primary and secondary outcome measuresPrimary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention.Secondary outcomessatisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception.ResultsPrimary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005).ConclusionsTelemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies.Trial registration numberNCT04139382.

Project description:BackgroundStudies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education.ObjectiveTo investigate women's acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India.DesignSecondary outcome of a randomised, controlled, non-inferiority trial.SettingOutpatient primary health care clinics in rural and urban Rajasthan, India.PopulationWomen were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85 mg/l and were below 18 years.MethodsAbortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible.Main outcome measuresWomen's acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups.Results731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%), in the home-assessment group preferred home-assessment in the future, as compared with 188 (70%) of women in the clinic follow-up group, who preferred clinic follow-up in the future (p < 0.001).ConclusionHome-assessment is highly acceptable among women in low-resource, and rural, settings. The choice to follow-up an early medical abortion according to women's preference should be offered to foster women's reproductive autonomy.Trial registrationClinicalTrials.gov NCT01827995.

Project description:ObjectiveTo inform UK service development to support medical abortion at home, appropriate for person and context.DesignRealist review SETTING/PARTICIPANTS: Peer-reviewed literature from 1 January 2000 to 9 December 2021, describing interventions or models of home abortion care. Participants included people seeking or having had an abortion.InterventionsInterventions and new models of abortion care relevant to the UK.Outcome measuresCausal explanations, in the form of context-mechanism-outcome configurations, to test and develop our realist programme theory.ResultsWe identified 12 401 abstracts, selecting 944 for full text assessment. Our final review included 50 papers. Medical abortion at home is safe, effective and acceptable to most, but clinical pathways and user experience are variable and a minority would not choose this method again. Having a choice of abortion location remains essential, as some people are unable to have a medical abortion at home. Choice of place of abortion (home or clinical setting) was influenced by service factors (appointment number, timing and wait-times), personal responsibilities (caring/work commitments), geography (travel time/distance), relationships (need for secrecy) and desire for awareness/involvement in the process. We found experiences could be improved by offering: an option for self-referral through a telemedicine consultation, realistic information on a range of experiences, opportunities to personalise the process, improved pain relief, and choice of when and how to discuss contraception.ConclusionsAcknowledging the work done by patients when moving medical abortion care from clinic to home is important. Patients may benefit from support to: prepare a space, manage privacy and work/caring obligations, decide when/how to take medications, understand what is normal, assess experience and decide when and how to ask for help. The transition of this complex intervention when delivered outside healthcare environments could be supported by strategies that reduce surprise or anxiety, enabling preparation and a sense of control.

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Simultaneous Compared With Interval Medical Abortion Regimens Where Home Use Is Restricted.

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Simultaneous Compared With Interval Medical Abortion Regimens Where Home Use Is Restricted.

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