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Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial.

ABSTRACT: Studies 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.To 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.Secondary outcome of a randomised, controlled, non-inferiority trial.Outpatient primary health care clinics in rural and urban Rajasthan, India.Women 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.Abortion 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.Women'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.731 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).Home-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.ClinicalTrials.gov NCT01827995.

SUBMITTER: Paul M

PROVIDER: S-EPMC4556554 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial.

Paul Mandira M Iyengar Kirti K Essén Birgitta B Gemzell-Danielsson Kristina K Iyengar Sharad D SD Bring Johan J Soni Sunita S Klingberg-Allvin Marie M

PloS one 20150901 9

<h4>Background</h4>Studies 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.<h4>Objective</h4>To 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.<h4>Design</h4> ...[more]

PMID: 26327217

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Project description:Post-abortion contraceptive use in India is low and the use of modern methods of contraception is rare, especially in rural areas. This study primarily compares contraceptive use among women whose abortion outcome was assessed in-clinic with women who assessed their abortion outcome at home, in a low-resource, primary health care setting. Moreover, it investigates how background characteristics and abortion service provision influences contraceptive use post-abortion.A randomized controlled, non-inferiority, trial (RCT) compared clinic follow-up with home-assessment of abortion outcome at 2 weeks post-abortion. Additionally, contraceptive-use at 3 months post-abortion was investigated through a cross-sectional follow-up interview with a largely urban sub-sample of women from the RCT. Women seeking abortion with a gestational age of up to 9 weeks and who agreed to a 2-week follow-up were included (n?=?731). Women with known contraindications to medical abortions, Hb?<?85 mg/l and aged below 18 were excluded. Data were collected between April 2013 and August 2014 in six primary health-care clinics in Rajasthan. A computerised random number generator created the randomisation sequence (1:1) in blocks of six. Contraceptive use was measured at 2 weeks among women successfully followed-up (n?=?623) and 3 months in the sub-set of women who were included if they were recruited at one of the urban study sites, owned a phone and agreed to a 3-month follow-up (n?=?114).There were no differences between contraceptive use and continuation between study groups at 3 months (76 % clinic follow-up, 77 % home-assessment), however women in the clinic follow-up group were most likely to adopt a contraceptive method at 2 weeks (62?±?12 %), while women in the home-assessment group were most likely to adopt a method after next menstruation (60?±?13 %). Fifty-two per cent of women who initiated a method at 2 weeks chose the 3-month injection or the copper intrauterine device. Only 4 % of women preferred sterilization. Caste, educational attainment, or type of residence did not influence contraceptive use.Simplified follow-up after early medical abortion will not change women's opportunities to access contraception in a low-resource setting, if contraceptive services are provided as intra-abortion services as early as on day one. Women's postabortion contraceptive use at 3 months is unlikely to be affected by mode of followup after medical abortion, also in a low-resource setting. Clinical guidelines need to encourage intra-abortion contraception, offering the full spectrum of evidence-based methods, especially long-acting reversible methods.Clinicaltrials.gov NCT01827995.

Project description:ObjectivesThe analysis aimed to assess the scale of interviewer effects on abortion survey responses, to compare interviewer effects between different question wordings and between direct and indirect approaches, and to identify interviewer and interview characteristics that explain interviewer effects on abortion reporting.Setting2018 Performance Monitoring for Action nationally representative household surveys from Côte d'Ivoire, Nigeria and Rajasthan, India.ParticipantsSurvey data from 20 016 interviews with reproductive age (15-49) women, selected using multistage stratified cluster sampling. Data from self-administered interviewer surveys and from a sample of health service delivery points that serve the female survey participants were also included.Primary outcome measuresOutcomes were the respondent's own experience of ever 'removing a pregnancy', their closest confidante's experience of pregnancy removal and the respondent's own experience of period regulation.ResultsSubstantial interviewer effects were observed, ranging from 7% in Côte d'Ivoire to 24% in Nigeria for pregnancy removal. Interviewer effects for survey questions that were designed to ask about abortion in a less stigmatising way were either similar to (9%-26% for confidante-reporting) or higher than (17%-32% for a question about period regulation) the pregnancy removal question. Interviewer and interview characteristics associated with abortion reporting included respondent-interviewer familiarity, the language of interview and the interviewer's comfort asking questions about abortion.ConclusionThis study highlights that questions designed to be less stigmatising may increase interviewer effects due to lower comprehension among respondents. Further work is needed to assess question wordings for different contexts. Selecting and training interviewers to ensure comfort asking questions about abortion is important for reproductive health surveys. Challenges for the use of 'insider' interviewers and the management of surveys in countries with high linguistic diversity are also identified.

Project description:BackgroundMonitoring abortion rates is highly relevant for demographic and public health considerations, yet its reliable estimation is fraught with uncertainty due to lack of complete national health facility service statistics and bias in self-reported survey data. In this study, we aim to test the confidante methodology for estimating abortion incidence rates in Nigeria, Cote d'Ivoire, and Rajasthan, India, and develop methods to adjust for violations of assumptions.MethodsIn population-based surveys in each setting, female respondents of reproductive age reported separately on their two closest confidantes' experience with abortion, in addition to reporting about their own experiences. We used descriptive analyses and design-based F tests to test for violations of method assumptions. Using post hoc analytical techniques, we corrected for biases in the confidante sample to improve the validity and precision of the abortion incidence estimates produced from these data.ResultsResults indicate incomplete transmission of confidante abortion knowledge, a biased confidante sample, but reduced social desirability bias when reporting on confidantes' abortion incidences once adjust for assumption violations. The extent to which the assumptions were met differed across the three contexts. The respondent 1-year pregnancy removal rate was 18.7 (95% confidence interval (CI) 14.9-22.5) abortions per 1000 women of reproductive age in Nigeria, 18.8 (95% CI 11.8-25.8) in Cote d'Ivoire, and 7.0 (95% CI 4.6-9.5) in India. The 1-year adjusted abortion incidence rates for the first confidantes were 35.1 (95% CI 31.1-39.1) in Nigeria, 31.5 (95% CI 24.8-38.1) in Cote d'Ivoire, and 15.2 (95% CI 6.1-24.4) in Rajasthan, India. Confidante two's rates were closer to confidante one incidences than respondent incidences. The adjusted confidante one and two incidence estimates were significantly higher than respondent incidences in all three countries.ConclusionsFindings suggest that the confidante approach may present an opportunity to address some abortion-related data deficiencies but require modeling approaches to correct for biases due to violations of social network-based method assumptions. The performance of these methodologies varied based on geographical and social context, indicating that performance may be better in settings where abortion is legally and socially restricted.

Project description:The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic.This study protocol describes a study that is a randomised, controlled, non-superiority trial. Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. The randomisation list will be generated using a computerized random number generator and opaque sealed envelopes with group allocation will be prepared. Randomization of the study participants will occur after the first clinical encounter with the doctor. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study this study protocol describes is to evaluate the efficacy of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This resulted in an optimized, tailor-made intervention and in the development of the pictorial instruction sheet with a guide on how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion.In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor.Clinicaltrials.gov NCT01827995. Registered 04 May 2013.

Project description:ObjectiveTo 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.MethodsWe 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).ResultsOf 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).ConclusionSimultaneous 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.

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.

Dataset Information

Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial.

Publications

Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial.

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