| 1. |
- Iyengar, Kirti, et al.
(författare)
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Home use of misoprostol for early medical abortion in a low resource setting : secondary analysis of a randomized controlled trial
- 2016
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Wiley. - 0001-6349 .- 1600-0412. ; 95:2, s. 173-181
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Although home use of misoprostol for early medical abortion is considered to be safe, effective and feasible, it has not become standard service delivery practice. The aim of this study was to compare the efficacy, safety, and acceptability of home use of misoprostol as compared to clinic misoprostol in a low-resource setting.MATERIAL AND METHODS: This was a secondary analysis of a randomised controlled trial conducted in 6 primary care clinics in India. Women seeking medical abortion up to 9 gestational weeks (n= 731) received mifepristone in the clinic, and were allocated either to home or clinic administration of misoprostol. Follow-up contact was after 10-15 days.RESULTS: Of 731 participants, 73% were rural and 55% had no formal education. Complete abortion rates in the home and clinic misoprostol groups were 94.2% and 94.4% respectively. The rate of adverse events was similar in both groups (0.3%). A greater proportion of home users (90.2%) said that they would opt for misoprostol at home in the event of a future abortion, than the proportion of clinic users (79.7%) that would opt for misoprostol at the clinic, in a similar situation (p=0.0002). Ninety six percent women using misoprostol at home or in the clinic were satisfied with their abortion experience.CONCLUSIONS: Home-use of misoprostol for early medical abortion is as effective and acceptable as clinic use, in low resource settings. Women should be offered a choice of this option regardless of distance of their residence from the clinic and communication facilities.
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| 2. |
- Iyengar, Kirti, et al.
(författare)
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Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial
- 2015
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Ingår i: The Lancet Global Health. - 2214-109X. ; 3:9, s. E537-E545
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 3. |
- Iyengar, Kirti, et al.
(författare)
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"Who Wants to Go Repeatedly to the Hospital?" : Perceptions and Experiences of Simplified Medical Abortion in Rajasthan, India
- 2016
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Ingår i: Global qualitative nursing research. - : SAGE PUBLICATIONS INC. - 2333-3936. ; 3
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 4. |
- Paul, Mandira, 1985-, et al.
(författare)
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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
- 2015
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 10:9
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 5. |
- Paul, Mandira, 1985-, et al.
(författare)
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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
- 2016
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Ingår i: BMC Public Health. - : Springer Science and Business Media LLC. - 1471-2458. ; 16:1
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 7. |
- Paul, Mandira, et al.
(författare)
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Simplified Follow-up after Medical Abortion using a Low-sensitivity Urinary Pregnancy Test and a Checklist in Rajasthan, India – Study Protocol and Intervention adaptation of a Randomised Control Trial
- 2014
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Konferensbidrag (refereegranskat)abstract
- BackgroundThe WHO suggests that simplification of the medical abortion regime will contribute to anincreased acceptability of medical abortion, among women as well as providers. It is expectedthat a home-based follow-up after a medical abortion will increase the willingness to opt formedical abortion as well as decrease the workload and service costs in the clinic. This studyprotocol describes an RCT that aims to evaluate the efficacy of home-based self-assessmentafter a medical abortion and the acceptability and feasibility of the intervention in a lowresourcesetting.Method/DesignThe study is a randomised, controlled, non-superiority trial that will evaluate the effectivenessand acceptability of self-assessment using a low-sensitivity pregnancy test and a checklist twoweeks after medical abortion. Women screened to participate in the study are those withunwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible womenrandomised to the self-assessment group will use the low-sensitivity pregnancy test and thechecklist at home, while the women in the clinic follow-up group will return to the clinic forroutine follow-up carried out by a doctor. To ensure feasibility of the self-assessmentintervention 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 resultedin the development of a pictorial instruction sheet for how to use the low-sensitivitypregnancy test and the checklist of danger signs after a medical abortion.DiscussionIn this paper, we will describe the study protocol for a randomised control trial investigatingthe efficacy of simplified follow-up in terms of home-based self-assessment, two weeks aftera medical abortion. Moreover, a description of the adaptation phase is included for a betterunderstanding of the implementation of the intervention in a setting where literacy is low andthe road-connections are poor.Trial registrationClinicaltrials.gov (No. NCT01827995)
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| 8. |
- Paul, Mandira, 1985-, et al.
(författare)
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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
- 2014
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Ingår i: BMC Women's Health. - : BioMed Central. - 1472-6874. ; 14
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Tidskriftsartikel (refereegranskat)abstract
- 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 designThe study is a randomised, controlled, non-superiority trial .MethodsWomen 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. DiscussionIn 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
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| 9. |
- Iyengar, Kirti
(författare)
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Simplifying medical abortion services in primary care settings in India
- 2016
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: Even in countries where abortion is legal, many women suffer mortality and morbidity from unsafe abortion. When faced with an unwanted pregnancy, women encounter many social, geographical, and health system level barriers in accessing safe abortion. Medical methods are far more amenable to be provided in primary care rural settings, however, in practice, women are required to make multiple clinic visits to receive medical abortion services. Two important measures to reduce the number of clinic visits after an early medical abortion, are eliminating the second visit by allowing home use of misoprostol and eliminating the third visit by allowing women to assess the outcome of their abortion on their own. However, most research on home use of misoprostol and on alternatives to routine clinic follow-up visits has been done in high-income countries or in urban areas of developing countries. There is little evidence on efficacy, safety and acceptability of home use of misoprostol and self-assessment approaches from rural areas of low resource settings. Objectives: The aims of this research were: (a) to assess the efficacy, feasibility, safety and acceptability of self assessment as compared to the routine clinic follow-up after early medical abortion, (b) to assess efficacy, safety and acceptability of home administration of misoprostol as compared to clinic use of misoprostol, and (c) to explore women’s experiences and perceptions of home use of misoprostol and of self-assessment of outcome of early medical abortion. Methods: The study was conducted in southern part of Rajasthan state in India, where 75% population is rural and only about half the women are literate. A randomised controlled, noninferiority trial was conducted at 6 health centres (3 rural, 3 urban) in 2013-14. Women seeking early medical abortion up to 9 weeks gestation were randomly assigned either to routine clinic follow-up or to self-assessment using a low-sensitivity pregnancy test at home. They were contacted through a home visit or phone call, 10-15 days later, to record the outcome of the abortion. The primary outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone /misoprostol. The non-inferiority margin for the risk difference was 5%. Secondary outcomes included safety, feasibility, interim visits, and acceptability. A secondary analysis of the data was carried out to compare the outcomes among women with home and clinic administration of misoprostol. In-depth interviews were conducted with 20 women who administered misoprostol at home and assessed their own outcome of abortion using a low-sensitivity pregnancy test, to explore their perceptions and experiences. Results: In the randomised controlled trial, 731 participants were recruited, of whom 700 were analysed for primary outcome (had a recorded primary outcome and who followed the clinical protocol). Overall rates of complete abortion, incomplete abortion and on-going pregnancy were 94.3%, 4.7% and 1.0%. Comparison of women in the clinic follow-up group and the home assessment groups showed that complete abortion rates and rates of surgical intervention were similar between the two groups, and that home assessment is non-inferior iii to clinic follow-up after an early medical abortion. Adverse outcomes were extremely rare in both groups. Eighteen percent of women made an interim visit. 80% women did the low-sensitivity pregnancy test on their own, without any reminder. Overall, 96% were satisfied with their medical abortion experience and there were no differences between the study groups. Significantly more women in the home-assessment group preferred home-assessment in the future, as compared with women in the clinic follow-up group, who preferred clinic followup in the event of a future medical abortion (p= 0.001). Comparison of women using home and clinic misoprostol groups showed that the outcomes related to efficacy, safety and satisfaction rates were comparable between the two groups. Non-compliance with use of misoprostol was higher among women assigned to clinic user than those assigned to home user (3.6% and 0.6% respectively). The time spent on clinic visits and travel was 5 hours extra for clinic users as compared to home users. A significantly greater proportion of home users said that they would opt for misoprostol at home in the event of a future abortion, than the proportion of clinic users that would opt for misoprostol at the clinic, in a similar situation (p= 0.0002). In-depth interviews revealed that almost all women preferred home use of misoprostol, since it allowed them to maintain confidentiality and to avoid difficulties related to childcare, housework and inconvenience of travel. On the day of misoprostol, women were confidently able to manage their abortions, and continue with routine housework. Even though most women were able to understand the outcome of their abortion through symptoms, they found it reassuring to do the pregnancy test to alleviate anxieties about retained products. Majority said they would prefer medical abortion involving a single visit in future. Conclusion: Our results confirm that self-assessment using low-sensitivity pregnancy test is an effective and safe approach to identify women with on-going pregnancies after an early medical abortion. Further, these studies also confirm that women are capable of administering misoprostol at home, without reduction in efficacy or safety. Women can confidently administer misoprostol at home, can conduct assessment of their abortion outcomes, and find it highly acceptable. Evidence generated by these studies is the only evidence thus far from a low resource rural setting that women with low literacy levels can feasibly assess the outcome of an early medical abortion and can safely use misoprostol at home. Service delivery guidelines should be revised and offer women a choice between home and clinic use of misoprostol and between self-assessment and clinic follow-up. In health systems, reducing the number of clinic visits would greatly enhance women’s access to safe abortion. Greater self-management of medical abortions would require that health systems enable and equip women with necessary information and supplies, and are available to provide backup care.
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