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2.
  • Atuhairwe, Susan, et al. (författare)
  • 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
  • Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 20:1
  • 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 Unsafe and outdated methods like sharp curettage are frequently used.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.
  • Bizjak, Isabella, et al. (författare)
  • Contraceptive uptake and compliance after structured contraceptive counseling - secondary outcomes of the LOWE trial
  • 2024
  • Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - 0001-6349 .- 1600-0412. ; 103:5, s. 873-883
  • Tidskriftsartikel (refereegranskat)abstract
    • INTRODUCTION: Highly effective long-acting reversible contraceptive (LARC) methods reduce unintended pregnancy rates; however, these methods are underutilized. The LOWE trial intervention provided structured contraceptive counseling resulting in increased uptake of LARC. This longitudinal follow up of the LOWE study assessed the long-term impact of the intervention by investigating the contraceptive use at 12 months with a focus on continued use of LARC.MATERIAL AND METHODS: In the cluster randomized LOWE trial, abortion, youth, and maternal health clinics were randomized to provide either structured contraceptive counseling (intervention) or standard contraceptive counseling (control). The intervention consisted of an educational video on contraceptive methods, key questions asked by the health care provider, a tiered effectiveness chart and a box of contraceptive models. Women ≥ age 18, who were sexually active or planned to be in the upcoming 6 months, could participate in the study. We assessed self-reported contraceptive use at three, six and 12 months. Contraceptive choice and switches were analyzed with descriptive statistics. Contraceptive use at 12 months and continued use of LARC were analyzed using mixed logistic regressions, with clinic included as a random effect. Analysis with imputed values were performed for missing data to test the robustness of results.RESULTS: Overall, at 12 months, women in the intervention group were more likely to be using a LARC method (aOR 1.90, 95% CI: 1.31-2.76) and less likely to be using a short-acting reversible contraceptive (SARC) method (aOR 0.66, 95% CI: 0.46-0.93) compared to the control group. Women counseled at abortion (aOR 2.97, 95% CI: 1.36-6.75) and youth clinics (aOR 1.81, 95% CI: 1.08-3.03) were more likely to be using a LARC method, while no significant difference was seen in maternal health clinics (aOR 1.84, 95% CI: 0.96-3.66). Among women initiating LARC, continuation rates at 12 months did not differ between study groups (63.9% vs. 63.7%). The most common reasons for contraceptive discontinuation were wish for pregnancy, followed by irregular bleeding, and mood changes.CONCLUSIONS: The LOWE trial intervention resulted in increased LARC use also at 12 months. Strategies on how to sustain LARC use needs to be further investigated.
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  • Cleeve, Amanda, et al. (författare)
  • 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
  • Ingår i: PLOS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 11:2
  • 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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6.
  • Emtell Iwarsson, Karin, et al. (författare)
  • Increasing uptake of long-acting reversible contraception with structured contraceptive counselling : cluster randomised controlled trial (the LOWE trial).
  • 2021
  • Ingår i: British Journal of Obstetrics and Gynecology. - : Wiley. - 1470-0328 .- 1471-0528. ; 128:9, s. 1546-1554
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVES: To evaluate the effect of structured contraceptive counselling on uptake of long-acting reversible contraceptives (LARCs), and pregnancy rates.DESIGN: Cluster randomised trial SETTING: Abortion, youth, and maternal health clinics in Stockholm, Sweden.POPULATION: Sexually active women ≥18 years without a wish for pregnancy seeking abortion and/or contraceptive counselling.METHODS: For participants in clinics randomised to intervention, trained health care providers implemented a study-specific intervention package designed for structured contraceptive counselling. Participants in the control clinics received routine counselling.MAIN OUTCOME MEASURES: Primary outcome was choice of LARCs at first visit. Secondary outcomes were LARC initiation at three months and pregnancy rates at three and 12 months. We used logistic mixed-effects models with random intercept for clinic to account for clustering.RESULTS: From September 2017 to May 2019, 28 randomised clinics enrolled 1364 participants. Analyses including 1338 subjects showed that more participants in the intervention compared to control group chose LARCs (267/658 (40.6%) versus 206/680 (30.3%), odds ratio (OR) 2.77, 95% CI 1.99 to 3.86). LARC initiation was higher in the intervention compared to the control group (213/528 (40.3%) versus 153/531 (28.8%), OR 1.74, 95% CI 1.22 to 2.49). At abortion clinics, pregnancy rate was significantly lower at 12 months in the intervention versus the control group (13/101 (12.9%) versus 28/103 (27.2%), OR 0.39, 95% CI 0.18 to 0.88).CONCLUSIONS: Structured contraceptive counselling increased LARC uptake in all clinics and significantly reduced unintended pregnancy rates in abortion clinics at 12 months follow-up.
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7.
  • Emtell Iwarsson, Karin, et al. (författare)
  • Long-acting reversible contraception and satisfaction with structured contraceptive counselling among non-migrant, foreign-born migrant and second-generation migrant women : evidence from a cluster randomised controlled trial (the LOWE trial) in Sweden.
  • 2022
  • Ingår i: BMJ Sexual & Reproductive Health. - : BMJ. - 2515-1991 .- 2515-2009. ; 48:2, s. 128-136
  • Tidskriftsartikel (refereegranskat)abstract
    • OBJECTIVE: This trial aimed to evaluate effects of structured contraceptive counselling among non-migrants, foreign-born migrants and second-generation migrants.METHODS: A cluster randomised controlled trial was conducted in 2017-2019 at abortion, youth and maternal health clinics in Stockholm, Sweden (the LOWE trial). Patients were eligible if they were 18 years or older, could understand Swedish or English (or if assisted by an interpreter), were sexually active or planning to be, and were seeking contraception for pregnancy prevention. We randomised clinics at a 1:1 allocation ratio to give either structured contraceptive counselling (intervention) or to maintain standard contraceptive counselling (control). Blinding was not deemed feasibile. A study-specific package for structured contraceptive counselling was used and comprised an educational video, an effectiveness chart, four key questions and a box with contraceptive models. Outcomes were effects of the intervention on long-acting reversible contraception (LARC) choice, initiation and use, and satisfaction with the intervention material among the participants.RESULTS: We involved 14 clinics in each of the intervention and control groups, respectively. A total of 1295 participants were included: 1010 non-migrants, 169 foreign-born migrants and 116 second-generation migrants. Participants in the intervention group chose LARC to a higher extent than the control group (adjusted OR (aOR) 2.85, 95% CI 2.04-3.99), had higher LARC initiation rates (aOR 2.90, 95% CI 1.97 to 4.27) and higher LARC use within the 12-month follow-up period (aOR 2.09, 95% CI 1.47 to 2.96). The majority of the participants who received the intervention package found all the different parts to be supportive in contraceptive choice. The effectiveness chart was the only part of the package that a higher proportion of foreign-born migrants (58/84, 69%) and second-generation migrants (40/54, 74.1%) found supportive in contraceptive choice compared to non-migrants (259/434, 59.7%) (p = 0.048).CONCLUSIONS: Structured contraceptive counselling increased LARC choice, initiation and use, controlled for participants' migration background. The effectiveness chart was found to be significantly more supportive among foreign-born migrants and second-generation migrants compared to non-migrants when choosing contraceptive methods.TRIAL REGISTRATION NUMBER: NCT03269357.
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8.
  • Envall, Niklas, 1984-, et al. (författare)
  • The use and access to contraception in Sweden during the COVID-19 pandemic period.
  • 2023
  • Ingår i: European journal of contraception & reproductive health care. - 1362-5187 .- 1473-0782. ; 28:5, s. 275-281
  • Tidskriftsartikel (refereegranskat)abstract
    • PURPOSE: Explore perceived access to, the need for, use of, and satisfaction with telemedicine services for contraceptive counselling and prescription-renewal-only during the COVID-19 pandemic, and the impact of the COVID-19 pandemic period on the choice and use of contraceptives.MATERIALS AND METHODS: Internet-based e-survey of Swedish women of fertile age, 16-49 years.RESULTS: In total, 1016 participants completed the survey. Most participants (69.7%) rated their access to contraceptive services 'as usual'. Among the remaining participants, a higher proportion rated their access as deteriorated (73.4%) compared to improved (26.6%; p < 0.001). In total, 38.0% reported a need for contraceptive counselling, whereof 14.0% had used telemedicine for counselling and reported high satisfaction. Telemedicine for prescription-renewal-only was used by 15.1% of the total population. Two per cent reported use of another contraceptive than their intended, whereof long-acting reversible contraceptives were the most common intended method. The proportion of current contraceptive users was lower than in 2017 (62.4% vs 71.1%, p < 0.001), and current users of long-acting reversible contraception decreased from 30.6% to 19.3% (p < 0.001).CONCLUSIONS: During the COVID-19 pandemic period, most women found their access to contraceptive services unaffected, but more women felt that it had deteriorated than improved. The use of telemedicine was low, and the use of contraception overall fell. Efforts are needed to raise awareness of available services, and TM-provided interventions for maintained quality of care and informed decision-making remain to be evaluated.SHORT CONDENSATION The COVID-19 period imposed a change in contraceptive service provision, and efforts are needed to raise awareness of available services, including telemedicine. Access to all contraceptives, including LARCs, is crucial and telemedicine-provided interventions need evaluation.
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9.
  • Envall, Niklas, 1984-, et al. (författare)
  • Use of contraception and attitudes towards contraceptive use in Swedish women : an internet-based nationwide survey
  • 2022
  • Ingår i: European journal of contraception & reproductive health care. - : Informa UK Limited. - 1362-5187 .- 1473-0782. ; 27:5, s. 409-417
  • Tidskriftsartikel (refereegranskat)abstract
    • PURPOSE: Explore contraceptive use, unmet need of and attitudes towards contraceptive use in Sweden. Secondly, to investigate knowledge of contraceptives, prevalence and outcomes of unintended pregnancies.MATERIALS AND METHODS: Internet based e-survey of Swedish women aged 16-49. The e-survey contained 49 questions with both spontaneous and multi-choice character on demographics, contraceptive use, knowledge of and attitudes towards contraception, importance of monthly bleeding, and experience of unintended pregnancy. The e-survey was closed when reaching the estimated sample size of 1000 respondents.RESULTS: A total of 1016 women participated, whereof 62.4% used contraception, 31.8% did not and 5.8% had stopped in the last 12 months. Unmet need for contraception was estimated at 17.2%. At least one unintended pregnancy was experienced by 19.9%. All women rated effectiveness as the most important characteristic of a contraceptive method.CONCLUSIONS: Use of contraception in Swedish women remains low, 62.4%, and the unmet need for contraception has increased to 17.2%. Method effectiveness and health benefits of hormonal contraception should be emphasised during contraceptive counselling, and actions are needed to target groups with low use of effective contraception as well as to reach those who never seek contraception.KEY MESSAGE Close to one third of Swedish women do not use contraception and one fifth have experienced at least one unintended pregnancy. Unmet need for contraception is high despite easy access and subsidies for young women.
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10.
  • Erlandsson, Kerstin, 1961-, et al. (författare)
  • Development of a tool to analyse what resources are needed to implement a midwife-led care framework : the MIDWIZE conceptual framework
  • 2022
  • Ingår i: Sexual & Reproductive HealthCare. - : Elsevier BV. - 1877-5756 .- 1877-5764. ; 33
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: A midwife led care project targeting to decide what to do to achieve the SDG 2030 in maternal and child health, made a project team develop a tool to analyse what health care systems need, to adopt the MIDWIZE Conceptual Framework. The MIDWIZE Conceptual Framework wish to introduce the comprehensive midwifery-managed care provided women in Sweden to other countries, regions, and units where the framework is not fully applied.METHODS: In order to determine what resource needs would have to be met to improve midwife led care, a tool was developed using Delphi study technique.RESULTS: Using Delphi study technique together with on-site visits to two Sub-Saharan African countries, members of a project team went to Ethiopia and Uganda, where they visited governments, clinical or educational institutions and together with African leaders developed availability and efficiency of a tool to determine resource needs.CONCLUSION: If at some future time, a single country, region or unit, might want to use the tool for quality improvement purpose of midwife led care, then the tool might aid in taking the first step to determine what resources might be required and what changes might be recommended as concerns policy at the clinical or educational institution level that are part of already existing health care structures.
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