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| 2. |
- Atuhairwe, Susan, et al.
(författare)
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Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians : study protocol for a randomized controlled equivalence trial
- 2019
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 20:1
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians.METHODS: A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 μg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant.DISCUSSION: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access.TRIAL REGISTRATION: ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.
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| 3. |
- Berger, Cecilia, et al.
(författare)
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Molecular characterization of PRM-associated endometrial changes, PAEC, following mifepristone treatment
- 2018
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Ingår i: Contraception. - : Elsevier. - 0010-7824 .- 1879-0518. ; 98:4, s. 317-322
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The progesterone receptor modulator (PRM) mifepristone holds the potential to be developed for regular contraception. However, long-term treatment can cause thickening of the endometrium and PRM-associated endometrial changes (PAEC). The objective of this study was to explore the molecular expression of endometrium displaying PAEC after mifepristone treatment in order to understand the future implications of PAEC and safety of long-term use. Study design: Endometrial biopsies were obtained from premenopausal women following 3 months of continuous mifepristone treatment. The biopsies were evaluated regarding occurrence of PAEC and followed up by a comparative analysis of gene expression in PAEC endometrium (n=7) with endometrium not displaying PAEC (n=4). Methods used included microarray analysis, Ingenuity Pathway Analysis (IPA) and real-time polymerase chain reaction. Results: Three genes relevant within endometrial function were up-regulated with PAEC: THY1 (p=.02), ADAM12 (p=.04) and TN-C (p=.04). The proliferation marker MKi67 was not altered (p=.31). None of the differentially regulated genes were involved in the endometrial cancer-signaling pathway (based on IPA knowledge database). Conclusion: The genes altered in endometrium displaying PAEC after 3 months of mifepristone exposure are mainly involved in the structural architecture of tissue. Implications: PAEC features may be explained by the altered genes and their networks affecting tissue architecture although not involved in endometrial cancer signaling pathways, and thus, treatment with mifepristone at this dosage does not show any adverse effect at endometrial level.
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| 5. |
- Cleeve, Amanda, et al.
(författare)
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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
- 2016
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Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 11:2
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 7. |
- Hognert, Helena, 1973, et al.
(författare)
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High birth rates despite easy access to contraception and abortion : a cross-sectional study.
- 2017
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Ingår i: Acta obstetricia et gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 96:12, s. 1414-1422
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Tidskriftsartikel (refereegranskat)abstract
- The aim was to describe and compare contraceptive use, fertility, birth and abortion rates in the Nordic countries.National data on births, abortions, fertility rate (1975-2013), redeemed prescriptions of hormonal contraceptives and sales figures of copper intrauterine devices (2008-2013) among women 15-49 years of age in the Nordic countries were collected and analysed.Use of hormonal contraceptives and copper intrauterine devices varied between 31-44%. The highest use was in Denmark (39-44%) and Sweden (40-42%). Combined hormonal contraception followed by the levonorgestrel-releasing intrauterine system were the most common methods. During 1975-2013 abortion rates decreased in Denmark (27-15/1000 women aged 15-44) and Finland (20-10), remained stable in Norway (≈16) and Sweden (≈20) and increased in Iceland (6 -15). Birth rates remained stable around 60/1000 women aged 15-44 in all countries except for Iceland where the birth rate decreased from 95-65. Abortion rates were highest in the age group 20-24 years. In the same age group Sweden had a lower contraceptive use (51%) compared to Denmark (59%) and Norway (56%) and a higher abortion rate 33/1000 compared to Denmark (25/1000) and Norway (27/1000).In contrast to the declining average fertility and birth rates in Europe, rates in the Nordic countries remain high and stable despite high contraceptive use and liberal access to abortion on womens' request. This article is protected by copyright. All rights reserved.
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- Håkansson, Miranda, 1992-, et al.
(författare)
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Human rights versus societal norms : a mixed methods study among healthcare providers on social stigma related to adolescent abortion and contraceptive use in Kisumu, Kenya
- 2018
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Ingår i: BMJ Global Health. - : BMJ. - 2059-7908. ; 3:2
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionAdolescent pregnancy represents a serious public health issue in sub-Saharan Africa, and stigmatising attitudes are contributing factors. This study investigates stigmatising attitudes related to adolescent pregnancy, abortion and contraceptive use among healthcare providers working with postabortion care (PAC) in a low-resource setting in Kenya.MethodsA mixed methods approach in a convergent design was utilised to capture attitudes related to abortion and contraceptive use among 86 (f=62; m=19) PAC providers in Kisumu, Kenya. Two Likert-scale questionnaires were used: the 18-item Stigmatising Attitudes, Beliefs and Actions Scale (SABAS) and the 7-item Contraceptive Use Stigma Scale (CUSS). 74 PAC providers responded to the SABAS, 44 to the CUSS and 12 participated in two focus group discussions. Descriptive statistics, psychometric tests of instruments and qualitative content analysis were conducted and reported in accordance with Consolidated Criteria for Reporting Qualitative Research.ResultsCronbach’s α coefficients for the total instrument was 0.88 (SABAS) and 0.84 (CUSS). The majority, 92% (68/74) agreed that a woman who has had an abortion should be treated equally to everyone else, 27% (20/74) considered abortion a sin and 30% (22/74) believed she will make abortion a habit. Contraceptive use among adolescent women was associated with promiscuity (39%; 17/44), hence contraceptives should only be available to married women (36%; 16/44), and 20% (9/44) believed that contraceptive use causes infertility. The providers encouraged women’s autonomy and their rights to sexual and reproductive health; however, unclear regulations reinforce religious and cultural beliefs, which hampers implementation of evidence-based contraceptive counselling.ConclusionStigmatising attitudes towards young women in need of abortion and contraception is common among PAC providers. Their work is characterised by a conflict between human rights and societal norms, thus highlighting the need for interventions targeting PAC providers to reduce stigma and misconceptions related to abortion and contraception among adolescent women.
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| 9. |
- 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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| 10. |
- 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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