Simplified follow-up after medical abortion using a low-sensitivity urinary pregnancy test and a pictorial instruction sheet in Rajasthan, India : study protocol and intervention adaptation of a randomised control trial

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. Trial design The study is a randomised, controlled, non-superiority trial . Methods Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. 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 is to evaluate the effectiveness 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 was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. Discussion 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. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013

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

Background: 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. Objective: 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. Design: Secondary outcome of a randomised, controlled, non-inferiority trial. Setting Outpatient primary health care clinics in rural and urban Rajasthan, India. Population: 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 < 85mg/l and were below 18 years. Methods: 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. Main outcome measures: 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. Results: 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). Conclusion: 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.

Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial

Background: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting. Methods: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995. Findings: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2.2%, 95% CI -5.9 to 1.6). One case of haemorrhage occurred in each group (rate of adverse events 0.3% in each group); no other adverse events were noted. Interpretation Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.

First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review

http://download.journals.elsevierhealth.com/pdfs/journals/0010-7824/PIIS0010782412006439.pdf

Two Distinct Oral Routes of Misoprostol in Mifepristone Medical Abortion. A Randomized Controlled Trial

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Latin American women's experiences with medical abortion in settings where abortion is legally restricted.

El aborto está legalmente restringido en la mayoría de América Latina donde 95 % de los 4.4 millones de abortos que se realizan anualmente son inseguros. El aborto con medicamentos es el uso de una droga o una combinación de drogas para interrupir el embarazo. Mifepristona seguida de misoprostol constituye el regimen más efectivo y recomendado. En los lugares donde no está disponible la mifepristona, se utiiza misoprostol solo. El aborto con medicamentos ha transformado radicalmente la práctica del aborto a nivel mundial, y particularmente en los contextos legalmente restrictivos. En América Latina, desde hace más de dos décadas, las mujeres utilizan el misoprostol para autoinducirse abortos. Este artículo resume los hallazgos de una revisión bibliográfica sobre las experiencias de las mujeres con el aborto con medicamentos en países latinoamericanos donde el aborto voluntario es ilegal. Las experiencias personales de las mujeres con el aborto con medicamentos son diversas y varían según el contexto, la edad, la historia reproductiva, el nivel socioeconómico y el conocimiento acerca del aborto con medicamentos así como las circunstancias físicas, emocionales y sociales que rodean el embarazo. Pero fundamentalmente, las experiencias están determinadas por la posibilidad de las mujeres de acceder a: 1) un aborto clandestino realizado bajo supervisión médica, o 2) información completa y precisa acerca del aborto con medicamentos, Otros factores clave incluyen el acceso a recursos económicos y apoyo emocional. Las mujeres valoran la seguridad y efectividad del aborto con medicamentos así como la privacidad que ofrece y la posibilidad de tener cerca a su pareja, amiga/o, o persona de su confianza durante el proceso. Las mujeres perciben al aborto con medicamentos como menos doloroso, más fácil, más seguro, más práctico, menos costoso, más natural y menos traumático que otros métodos abortivos. Que sea auto-inducido y que evite el procedimiento quirúrgico también son señalados como ventajas. Las principales desventajas identificadas son que es doloroso y que lleva tiempo para que se complete. Otros aspectos evaluados negativamente incluyen los efectos secundarios, el sangrado prolongado, la posibilidad de que no sea efectivo, y el hecho de que algunas mujeres eventualmente deban solicitar atención médica en una institución donde sean sancionadas por haberse practicado un aborto y hasta denunciadas a la policía.

Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review

OBJETIVO: Comparar la efectividad, la seguridad y la aceptación de los abortos médicos practicados en el domicilio con aquellos realizados en la clínica. MÉTODOS: Se realizó una búsqueda sistemática de ensayos clínicos controlados aleatorizados y de estudios de cohortes prospectivos, comparando los abortos médicos realizados en el domicilio y en la clínica. Se realizaron búsquedas en el Registro Central de Cochrane de Ensayos Controlados, EMBASE, MEDLINE y Popline. Los resultados de interés principales fueron el fracaso para abortar completamente, los efectos secundarios y la aceptabilidad. Se calcularon las tasas de probabilidad y sus intervalos de confianza (IC) del 95%. Se reunieron los cálculos aproximados utilizando un modelo de efectos aleatorios. RESULTADOS: Nueve estudios cumplieron los criterios de inclusión (n=4522 participantes).Todos fueron estudios de cohortes prospectivos que utilizaron mifepristona y misoprostol para inducir al aborto. El aborto completo se consiguió en el 86- 97% de las mujeres que se sometieron a un aborto en el domicilio (n=3478) y entre el 80% y el 99% de aquellas mujeres que se sometieron a un aborto en una clínica (n = 1044). Los análisis agrupados de todos los estudios no mostraron diferencias en las tasas de aborto completo entre los grupos (tasa de probabilidad=0,8; IC del 95%: 0,5-1,5). Las complicaciones graves del aborto fueron poco frecuentes. El dolor y los vómitos duraron 0,3 días más en aquellas mujeres a las que se les administró misoprostol en el domicilio, en comparación con las que recibieron el tratamiento en la clínica. Las mujeres que optaron por un aborto médico en el domicilio mostraron un mayor grado de satisfacción, que las llevaría a elegir el método de nuevo y recomendárselo a una amiga, que aquellas mujeres que abortaron en la clínica. CONCLUSIÓN: El aborto en el domicilio es seguro siempre que el lugar cuente con las condiciones incluidas en los estudios. Los estudios de cohortes prospectivos por país no han mostrado diferencias en cuanto a efectividad o aceptabilidad entre abortos médicos en el domicilio y en la clínica.

Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days

BACKGROUND: From 2001 to March 2006, Planned Parenthood Federation of America (Planned Parenthood) health centers throughout the United States provided medical abortions principally by a regimen of oral mifepristone, followed 24-48 h later by vaginal misoprostol. In late March 2006, analyses of serious uterine infections following medical abortions led Planned Parenthood to change the route of misoprostol administration and to employ additional measures to minimize subsequent serious uterine infections. In August 2006, we conducted an extensive audit of medical abortions with the new buccal misoprostol regimen so that patients could be given accurate information about the success rate of the new regimen. OBJECTIVES: We sought to evaluate the effectiveness of the buccal medical abortion regimen and to examine correlates of its success during routine service delivery. METHODS: In 2006, audits were conducted in 10 large urban service points to estimate the success rates of the buccal regimen. Success was defined as medical abortion without vacuum aspiration. These audits also permitted estimates of success rates with oral misoprostol following mifepristone in a subset in which 98% of the subjects stemmed from two sites. RESULTS: The effectiveness of the buccal misoprostol-mifepristone regimen was 98.3% for women with gestational ages below 60 days. The oral misoprostol-mifepristone regimen, used by 278 women with a gestational age below 50 days, had a success rate of 96.8%. CONCLUSION: In conjunction with 200 mg of mifepristone, use of 800 mcg of buccal misoprostol up to 59 days of gestation is as effective as the use of 800 mcg of vaginal misoprostol up to 63 days of gestation.

Knowledge of medical abortion among Brazilian medical students

OBJECTIVE: To assess the knowledge of Brazilian medical students regarding medical abortion (MA) and the use of misoprostol for MA, and to investigate factors influencing their knowledge. METHODS: All students from 3 medical schools in São Paulo State were invited to complete a pretested structured questionnaire with precoded response categories. A set of 12 statements on the use and effects of misoprostol for MA assessed their level of knowledge. Of about 1260 students invited to participate in the study, 874 completed the questionnaire, yielding a response rate of 69%. The Ï (2) test was used for the bivariate analysis, which was followed by multiple regression analysis. RESULTS: Although all students in their final year of medical school had heard of misoprostol for termination of pregnancy, and 88% reported having heard how to use it, only 8% showed satisfactory knowledge of its use and effects. Academic level was the only factor associated with the indicators of knowledge investigated. CONCLUSION: The very poor knowledge of misoprostol use for MA demonstrated by the medical students surveyed at 3 medical schools makes the review and updating of the curriculum urgently necessary.

Women’s experiences with the use of medical abortion in a legally restricted context: the case of Argentina

This article presents the findings of a qualitative study exploring the experiences of women living in Buenos Aires Metropolitan Area, Argentina, with the use of misoprostol for inducing an abortion. We asked women about the range of decisions they had to make, their emotions, the physical experience, strategies they needed to use, including seeking health care advice and in dealing with a clandestine medical abortion, and their overall evaluation of the experience. An in-depth interview schedule was used. The women had either used misoprostol and sought counselling or care at a public hospital (n=24) or had used misoprostol based on the advice of a local hotline, information from the internet or from other women (n=21). Four stages in the women’s experiences were identified: how the decision to terminate the pregnancy was taken, how the medication was obtained, how the tablets were used, and reflections on the outcome whether or not they sought medical advice. Safety and privacy were key in deciding to use medical abortion. Access to the medication was the main obstacle, requiring a prescription or a friendly drugstore. Correct information about the number of pills to use and dosage intervals was the least easy to obtain and caused concerns. The possibility of choosing a time of privacy and having the company of a close one was highlighted as a unique advantage of medical abortion. Efforts to improve abortion law, policy and service provision in Argentina in order to ensure the best possible conditions for use of medical abortion by women should be redoubled.

Does mode of follow-up influence contraceptive use after medical abortion in a low-resource setting? Secondary outcome analysis of a non-inferiority randomized controlled trial

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT01827995.

“Who wants to go repeatedly to the hospital?” : Perceptions and experiences of simplified medical abortion in Rajasthan, India

The aim of this study is to explore women's experiences and perceptions of home use of misoprostol and of the self-assessment of the outcome of early medical abortion in a low-resource setting in India. In-depth interviews were conducted with 20 women seeking early medical abortion, who administered misoprostol at home and assessed their own outcome of abortion using a low-sensitivity pregnancy test. With home use of misoprostol, women were able to avoid inconvenience of travel, child care, and housework, and maintain confidentiality. The use of a low-sensitivity pregnancy test alleviated women's anxieties about retained products. Majority said they would prefer medical abortion involving a single visit in future. This study provides nuanced understanding of how women manage a simplified medical abortion in the context of low literacy and limited communication facilities. Service delivery guidelines should be revised to allow women to have medical abortion with fewer visits.

Medical students are afraid to include abortion in their future practices : in-depth interviews in Maharastra, India

BACKGROUND: Unsafe abortions are estimated to cause eight per-cent of maternal mortality in India. Lack of providers, especially in rural areas, is one reason unsafe abortions take place despite decades of legal abortion. Education and training in reproductive health services has been shown to influence attitudes and increase chances that medical students will provide abortion care services in their future practice. To further explore previous findings about poor attitudes toward abortion among medical students in Maharastra, India, we conducted in-depth interviews with medical students in their final year of education. METHOD: We used a qualitative design conducting in-depth interviews with twenty-three medical students in Maharastra applying a topic guide. Data was organized using thematic analysis with an inductive approach. RESULTS: The participants described a fear to provide abortion in their future practice. They lacked understanding of the law and confused the legal regulation of abortion with the law governing gender biased sex selection, and concluded that abortion is illegal in Maharastra. The interviewed medical students' attitudes were supported by their experiences and perceptions from the clinical setting as well as traditions and norms in society. Medical abortion using mifepristone and misoprostol was believed to be unsafe and prohibited in Maharastra. The students perceived that nurse-midwives were knowledgeable in Sexual and Reproductive Health and many found that they could be trained to perform abortions in the future. CONCLUSIONS: To increase chances that medical students in Maharastra will perform abortion care services in their future practice, it is important to strengthen their confidence and knowledge through improved medical education including value clarification and clinical training.

Women's acceptability of misoprostol treatment for incomplete abortion by midwives and physicians : secondary outcome analysis from a randomized controlled equivalence trial at district level in Uganda

OBJECTIVE: This study aimed to assess women´s acceptability of diagnosis and treatment of incomplete abortion with misoprostol by midwives, compared with physicians. METHODS: This was an analysis of secondary outcomes from a multi-centre randomized controlled equivalence trial at district level in Uganda. Women with first trimester incomplete abortion were randomly allocated to clinical assessment and treatment with misoprostol by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and stratified for health care facility. Acceptability was measured in expectations and satisfaction at a follow up visit 14-28 days following treatment. Analysis of women's overall acceptability was done using a generalized linear mixed-effects model with an equivalence range of -4% to 4%. The study was not masked. The trial is registered at ClinicalTrials.org, NCT 01844024. RESULTS: From April 2013 to June 2014, 1108 women were assessed for eligibility of which 1010 were randomized (506 to midwife and 504 to physician). 953 women were successfully followed up and included in the acceptability analysis. 95% (904) of the participants found the treatment satisfactory and overall acceptability was found to be equivalent between the two study groups. Treatment failure, not feeling calm and safe following treatment, experiencing severe abdominal pain or heavy bleeding following treatment, were significantly associated with non-satisfaction. No serious adverse events were recorded. CONCLUSIONS: Treatment of incomplete abortion with misoprostol by midwives and physician was highly, and equally, acceptable to women. TRIAL REGISTRATION: ClinicalTrials.gov NCT01844024.