| 1. |
- 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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| 2. |
- 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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| 3. |
- Sjöström, Susanne, et al.
(författare)
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Medical students are afraid to include abortion in their future practices : in-depth interviews in Maharastra, India
- 2016
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Ingår i: BMC Medical Education. - : Springer Science and Business Media LLC. - 1472-6920. ; 16
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 4. |
- Kilander, Helena, et al.
(författare)
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IMplementing best practice post-partum contraceptive services through a quality imPROVEment initiative for and with immigrant women in Sweden (IMPROVE it) : a protocol for a cluster randomised control trial with a process evaluation
- 2023
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Ingår i: BMC Public Health. - : BioMed Central (BMC). - 1471-2458. ; 23:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Immigrant women’s challenges in realizing sexual and reproductive health and rights (SRHR) are exacerbated by the lack of knowledge regarding how to tailor post-partum contraceptive services to their needs. Therefore, the overall aim of the IMPROVE-it project is to promote equity in SRHR through improvement of contraceptive services with and for immigrant women, and, thus, to strengthen women’s possibility to choose and initiate effective contraceptive methods post-partum.Methods: This Quality Improvement Collaborative (QIC) on contraceptive services and use will combine a cluster randomized controlled trial (cRCT) with a process evaluation. The cRCT will be conducted at 28 maternal health clinics (MHCs) in Sweden, that are the clusters and unit of randomization, and include women attending regular post-partum visits within 16 weeks post birth. Utilizing the Breakthrough Series Collaborative model, the study’s intervention strategies include learning sessions, action periods, and workshops informed by joint learning, co-design, and evidence-based practices. The primary outcome, women’s choice of an effective contraceptive method within 16 weeks after giving birth, will be measured using the Swedish Pregnancy Register (SPR). Secondary outcomes regarding women’s experiences of contraceptive counselling, use and satisfaction of chosen contraceptive method will be evaluated using questionnaires completed by participating women at enrolment, 6 and 12 months post enrolment. The outcomes including readiness, motivation, competence and confidence will be measured through project documentation and questionnaires. The project’s primary outcome involving women’s choice of contraceptive method will be estimated by using a logistic regression analysis. A multivariate analysis will be performed to control for age, sociodemographic characteristics, and reproductive history. The process evaluation will be conducted using recordings from learning sessions, questionnaires aimed at participating midwives, intervention checklists and project documents.Discussion: The intervention’s co-design activities will meaningfully include immigrants in implementation research and allow midwives to have a direct, immediate impact on improving patient care. This study will also provide evidence as to what extent, how and why the QIC was effective in post-partum contraceptive services.Trial registration: NCT05521646, August 30, 2022.
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| 5. |
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| 6. |
- Paul, Mandira, 1985-
(författare)
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Simplifying Reproductive Health in Low-Resource Settings : Access to medical abortion and contraceptive choice, the importance of gendered structures in Rajasthan
- 2015
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- India introduced family planning in the ‘50s, legalized abortion in the ‘70s, and accomplished a remarkable drop in maternal mortality and fertility since 1990. Nevertheless, abortions account for a large proportion of maternal deaths, and sterilization is the most frequently used contraception. This thesis aims to identify the means to simplify and increase access to reproductive health in low-resource settings, focusing on abortion and contraception in Rajasthan.A randomized controlled trial compared simplified follow-up, where women assess their abortion outcome at home after early medical abortion, with in-clinic follow-up. Additionally, contraceptive use was compared between study groups post-abortion. In order to explore young women’s opportunities to access reproductive health services in the area, we conducted in-depth interviews with recently-married women.Women in the home-assessment group preferred home-assessment in the future to a greater extent than the women in the clinic follow-up group, who preferred in-clinic follow-up. Complete abortions were reported in 95% of women in the ‘home-assessment group’ and 93% in the ‘in-clinic group’, suggesting that efficacy of simplified follow-up is non-inferior to in-clinic follow-up. A majority (81%) of women carried out the pregnancy test and found it easy to use. Women (96%) were satisfied with their abortion. There were no differences in contraceptive use between study groups at three months; however, women in the ‘in-clinic group’ were most likely to initiate contraception at two weeks. A majority of women preferred the three-month injection, while only 4% preferred sterilization. The recently-married women considered reversible contraception to be unfeasible due to misconceptions and taboos, yet women wanted effective contraception because their current use of traditional methods resulted in unintended pregnancies. Abortions were common, and were procured from private or informal providers.Allowing women to take an active role in reproductive health services can enable simplification of, and access to, reproductive services in low-resource settings as well as in other settings. Simplifying medical abortion, providing contraception ‘intra-abortion’, and offering a context-appropriate and effective means of contraception, creates a great potential to increase access to reproductive health services and can result in a more equal society where women, and men, can attain their sexual and reproductive rights.
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| 7. |
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| 8. |
- Kopp Kallner, Helena, et al.
(författare)
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Use of Contraception and Attitudes towards Contraceptive Use in Swedish Women : A Nationwide Survey
- 2015
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 10:5
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To describe contraceptive use and attitudes towards contraceptive use in Sweden which has the highest abortion rate in Western Europe. Secondary objectives were to investigate knowledge of contraceptive methods and outcomes of unplanned and unwanted pregnancies.Design: Telephone survey.Setting: National survey of women living in Sweden.Population: Women between 16 and 49 years.Methods: The survey contained 22 questions with free text and multi choice answers on demographics, contraceptive use, knowledge of and attitudes towards contraception, the importance of monthly bleeding and experience of unintended pregnancy.Main Outcome Measures: Distribution of use of contraceptive methods and non-use of contraception among Swedish women. Prevalence and outcome of unintended pregnancies.Results: A total of 1001 women participated in the survey. Of all women, 721/1001 (72.1%) currently used contraception whereas 268/1001 (26.8%) women did not. Long acting reversible contraception, (LARC; implant and intra uterine contraception) was used by 24.3% of women. The unmet need of contraception in Sweden was estimated at 8.9% (89/1001 women). A total of 781 (78%) women had never experienced an unintended pregnancy whereas 220 (22%) women had had at least one unintended pregnancy. Users and non-users alike stated that one of the most important characteristics of a contraceptive method is its effectiveness.Conclusions: Sweden has a large unmet need for contraception. Furthermore, a large proportion of women have experienced at least one unintended pregnancy. Increasing contraceptive use and promotion of LARC is a possible way forward in the effort to reduce the rates of unwanted pregnancies.
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| 9. |
- Makenzius, Marlene, et al.
(författare)
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Post-abortion care with misoprostol - equally effective, safe and accepted when administered by midwives compared to physicians : a randomised controlled equivalence trial in a low-resource setting in Kenya
- 2017
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 7:10
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To assess the effectiveness of midwives administering misoprostol to women with incomplete abortion seeking post-abortion care (PAC), compared with physicians.DESIGN: A multicentre randomised controlled equivalence trial. The study was not masked.SETTINGS: Gynaecological departments in two hospitals in a low-resource setting, Kenya.POPULATION: Women (n=1094) with incomplete abortion in the first trimester, seeking PAC between 1 June 2013 to 31 May 2016. Participants were randomly assigned to receive treatment from midwives or physicians. 409 and 401 women in the midwife and physician groups, respectively, were included in the per-protocol analysis.INTERVENTIONS: 600 µg misoprostol orally, and contraceptive counselling by a physician or midwife.MAIN OUTCOME MEASURES: Complete abortion not needing surgical intervention within 7-10 days. The main outcome was analysed on the per-protocol population with a generalised estimating equation model. The predefined equivalence range was -4% to 4%. Secondary outcomes were analysed descriptively.RESULTS: The proportion of complete abortion was 94.8% (768/810): 390 (95.4%) in the midwife group and 378 (94.3%) in the physician group. The proportion of incomplete abortion was 5.2% (42/810), similarly distributed between midwives and physicians. The model-based risk difference for midwives versus physicians was 1.0% (-4.1 to 2.2). Most women felt safe (97%; 779/799), and 93% (748/801) perceived the treatment as expected/easier than expected. After contraceptive counselling the uptake of a contraceptive method after 7-10 days occurred in 76% (613/810). No serious adverse events were recorded.CONCLUSIONS: Treatment of incomplete abortion with misoprostol provided by midwives is equally effective, safe and accepted by women as when administered by physicians in a low-resource setting. Systematically provided contraceptive counselling in PAC is effective to mitigate unmet need for contraception.TRIAL REGISTRATION NUMBER: NCT01865136; Results.
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| 10. |
- 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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