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- 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 Unsafe and outdated methods like sharp curettage are frequently used.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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- Byamugisha, Josaphat K
(författare)
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Emergency contraception among young people in Uganda : user and provider perspectives
- 2007
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Background: The maternal mortality ratio for Uganda is 435/100,000 live births. Between 12-30 percent of the maternal deaths are due to induced abortions. According to the 2007 Uganda demographic and health survey (UDHS), the contraceptive prevalence rate was 24 percent and only 18 percent used modern contraceptives. The unmet need for family planning (FP) was 41 percent. Emergency contraception (EC) was officially launched in Uganda in November 1998 by the Ministry of Health with the aim of strengthening reproductive health. Aim: This thesis explores and analyzes factors influencing accessibility, utilization and acceptability of emergency contraception among young people in Kampala, Uganda. Materials and methods: The first phase of the study was exploratory. Four key informant interviews (KII), and seven focus group discussions (FGDs) were conducted including two male-only, two female-only and three groups with both male and female (I).The transcribed material was analyzed for latent content. In a cross sectional study at Makerere University, 379 students answered a self-administered questionnaire (II). Two-hundred forty-seven health care workers selected from 894 health units in Kampala completed a self-administered questionnaire about their knowledge and prescribing habits of EC (III).To study the acceptability of two EC Pill regimens, 337 women were enrolled in a randomized clinical trial in Kampala, Uganda. Women requesting EC pills within 72 hours after unprotected sexual intercourse received either levonorgestrel (LNG) or combined oral contraceptive pills (Yuzpe regimen). The women returned for follow up after three days and a follow-up interview was performed after one year (IV). Results: Participants expressed ambivalence about EC pills. The method was generally recommended, but only to the right people , in this context being those aged 18 years and above (I). Less than half of the students (45.1%) had ever heard about EC Pills. The most common sources of information about EC were friends (34%) and media (24.8%). The ever pregnancy rate was 3.4 percent and 42 percent were in a steady relationship of three or more months. Among the 14.5 percent contraceptive ever users, the most common methods were condoms (48.9%) and withdrawal (23.4%). Thirty-five percent did not know when in the menstrual cycle they were likely to conceive (II). Among the HCWs, 80 percent had ever heard of EC. The Yuzpe regimen was the most commonly mentioned and prescribed method of EC. The HCWs attitudes toward EC were generally positive and it was suggested that the community should be informed and sensitized about EC. There was a significant difference between having had a family planning educational update or not in the last year and knowledge of EC (p value 0.005) (III). LNG had significantly fewer side-effects than the Yuzpe regimen (p < 0.001). There was a significant association between having worries about the method and experiencing the side-effects (p < 0.001). Both EC Pill regimens were acceptable for use by the studied women, but this could be because most (81%) were prime users of EC. The majority would recommend the EC Pill regimens for use by other clients (IV). Conclusions: User and potential-user perceptions are crucial in the accessibility and utilization of EC Pill (I). Knowledge about EC and fertility awareness was low among the female first year university students. Friends and the media are an important source of EC information (II). Most HCWs were aware of EC, but some lacked important knowledge on its use and available methods (III). LNG is a superior option to the Yuzpe regimen, and should be promoted as the recommended EC Pill. Worries about the EC Pill, including the mechanisms of action, may influence the experience of side-effects and should be explored further (IV).
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- 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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- Klingberg-Allvin, Marie, et al.
(författare)
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Comparison of treatment of incomplete abortion with misoprostol by physicians and midwives at district level in Uganda : a randomised controlled equivalence trial
- 2015
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 385:9985, s. 2392-2398
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Misoprostol is established for the treatment of incomplete abortion but has not been systematically assessed when provided by midwives at district level in a low-resource setting. We investigated the effectiveness and safety of midwives diagnosing and treating incomplete abortion with misoprostol, compared with physicians.METHODS: We did a multicentre randomised controlled equivalence trial at district level at six facilities in Uganda. Eligibility criteria were women with signs of incomplete abortion. We randomly allocated women with first-trimester incomplete abortion to clinical assessment and treatment with misoprostol either by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and was stratified for study site. Primary outcome was complete abortion not needing surgical intervention within 14-28 days after initial treatment. The study was not masked. Analysis of the primary outcome was done on the per-protocol population with a generalised linear-mixed effects model. The predefined equivalence range was -4% to 4%. The trial was registered at ClinicalTrials.gov, number NCT01844024.FINDINGS: From April 30, 2013, to July 21, 2014, 1108 women were assessed for eligibility. 1010 women were randomly assigned to each group (506 to midwife group and 504 to physician group). 955 women (472 in the midwife group and 483 in the physician group) were included in the per-protocol analysis. 452 (95·8%) of women in the midwife group had complete abortion and 467 (96·7%) in the physician group. The model-based risk difference for midwife versus physician group was -0·8% (95% CI -2·9 to 1·4), falling within the predefined equivalence range (-4% to 4%). The overall proportion of women with incomplete abortion was 3·8% (36/955), similarly distributed between the two groups (4·2% [20/472] in the midwife group, 3·3% [16/483] in the physician group). No serious adverse events were recorded.INTERPRETATION: Diagnosis and treatment of incomplete abortion with misoprostol by midwives is equally safe and effective as when provided by physicians, in a low-resource setting. Scaling up midwives' involvement in treatment of incomplete abortion with misoprostol at district level would increase access to safe post-abortion care.FUNDING: The Swedish Research Council, Karolinska Institutet, and Dalarna University.
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- Saito, Makoto, et al.
(författare)
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Pregnancy outcomes after first-trimester treatment with artemisinin derivatives versus non-artemisinin antimalarials: a systematic review and individual patient data meta-analysis
- 2023
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 401:10371, s. 118-130
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Tidskriftsartikel (refereegranskat)abstract
- Background: Malaria in the first trimester of pregnancy is associated with adverse pregnancy outcomes. Artemisinin-based combination therapies (ACTs) are a highly effective, first-line treatment for uncomplicated Plasmodium falciparum malaria, except in the first trimester of pregnancy, when quinine with clindamycin is recommended due to concerns about the potential embryotoxicity of artemisinins. We compared adverse pregnancy outcomes after artemisinin-based treatment (ABT) versus non-ABTs in the first trimester of pregnancy. Methods: For this systematic review and individual patient data (IPD) meta-analysis, we searched MEDLINE, Embase, and the Malaria in Pregnancy Library for prospective cohort studies published between Nov 1, 2015, and Dec 21, 2021, containing data on outcomes of pregnancies exposed to ABT and non-ABT in the first trimester. The results of this search were added to those of a previous systematic review that included publications published up until November, 2015. We included pregnancies enrolled before the pregnancy outcome was known. We excluded pregnancies with missing estimated gestational age or exposure information, multiple gestation pregnancies, and if the fetus was confirmed to be unviable before antimalarial treatment. The primary endpoint was adverse pregnancy outcome, defined as a composite of either miscarriage, stillbirth, or major congenital anomalies. A one-stage IPD meta-analysis was done by use of shared-frailty Cox models. This study is registered with PROSPERO, number CRD42015032371. Findings: We identified seven eligible studies that included 12 cohorts. All 12 cohorts contributed IPD, including 34 178 pregnancies, 737 with confirmed first-trimester exposure to ABTs and 1076 with confirmed first-trimester exposure to non-ABTs. Adverse pregnancy outcomes occurred in 42 (5·7%) of 736 ABT-exposed pregnancies compared with 96 (8·9%) of 1074 non-ABT-exposed pregnancies in the first trimester (adjusted hazard ratio [aHR] 0·71, 95% CI 0·49–1·03). Similar results were seen for the individual components of miscarriage (aHR=0·74, 0·47–1·17), stillbirth (aHR=0·71, 0·32–1·57), and major congenital anomalies (aHR=0·60, 0·13–2·87). The risk of adverse pregnancy outcomes was lower with artemether–lumefantrine than with oral quinine in the first trimester of pregnancy (25 [4·8%] of 524 vs 84 [9·2%] of 915; aHR 0·58, 0·36–0·92). Interpretation: We found no evidence of embryotoxicity or teratogenicity based on the risk of miscarriage, stillbirth, or major congenital anomalies associated with ABT during the first trimester of pregnancy. Given that treatment with artemether–lumefantrine was associated with fewer adverse pregnancy outcomes than quinine, and because of the known superior tolerability and antimalarial effectiveness of ACTs, artemether–lumefantrine should be considered the preferred treatment for uncomplicated P falciparum malaria in the first trimester. If artemether–lumefantrine is unavailable, other ACTs (except artesunate–sulfadoxine–pyrimethamine) should be preferred to quinine. Continued active pharmacovigilance is warranted.
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