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Beverly Winikoff - One of the best experts on this subject based on the ideXlab platform.
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a randomized controlled trial of 400 μg sublingual misoprostol versus manual vacuum aspiration for the treatment of Incomplete Abortion in two egyptian hospitals
International Journal of Gynecology & Obstetrics, 2010Co-Authors: Rasha Dabash, Jennifer Blum, Mohamed Cherine Ramadan, E Darwish, Nevine Hassanein, Beverly WinikoffAbstract:Abstract Objective To compare the safety, efficacy, and acceptability of 400-μg sublingual misoprostol with that of manual vacuum aspiration (MVA) in 2 Egyptian hospitals. Methods Participating women were randomized to either MVA or misoprostol treatment for Incomplete Abortion. The primary outcome, complete uterine evacuation, was determined 1 week later, as were adverse effects, change in hemoglobin, acceptability, and satisfaction. Results Complete uterine evacuation was achieved in 98.3% of women who received misoprostol and 99.7% who underwent MVA (relative risk [RR] 0.99; 95% confidence interval [CI], 0.97–1.00). A decrease in hemoglobin of 2 g/dL or more was comparably rare in the 2 groups (0.3% misoprostol vs 0.9% MVA; RR 0.34 [95% CI, 0.04–3.21]). Mean change in hemoglobin was also clinically similar (–0.5 g/dL misoprostol vs –0.4 g/dL MVA; P Conclusion The high efficacy, safety, and acceptability of 400-μg sublingual misoprostol indicate that it is analogous to surgery as a first-line treatment for Incomplete Abortion. Misoprostol might improve post-Abortion care when resources are limited and surgical treatment is unavailable.
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two routes of administration for misoprostol in the treatment of Incomplete Abortion a randomized clinical trial
Contraception, 2009Co-Authors: Ayisha Diop, Sheila Raghavan, Jeanpierre Rakotovao, Rodica Comendant, Paul D Blumenthal, Beverly WinikoffAbstract:Abstract Background This study was conducted to compare the safety, effectiveness and acceptability of 400 mcg sublingual misoprostol and 600 mcg oral misoprostol for treatment of Incomplete Abortion. Study Design We used an open-label randomized controlled trial conducted from July 2005 to August 2006 in a large tertiary level maternity hospital in Antananarivo, Madagascar, and a large tertiary level hospital in Chisinau, Moldova. Three hundred consenting women seeking treatment for clinically diagnosed Incomplete Abortion with uterine size ≤12 weeks since last menstrual period were randomized to misoprostol either 600 mcg orally or 400 mcg sublingually. The primary outcome measure was the complete resolution of clinical signs and symptoms of Incomplete Abortion without need for surgical intervention. Women were seen for follow-up on Day 7 and, if necessary, on Day 14 to assess Abortion status. The study was powered to detect a 7% difference in efficacy with a total of 142 women required in each arm. Results Efficacy rates were 94.6% and 94.5%, for the oral and sublingual routes, respectively (RR: 1.00, 95% CI=0.95–1.06, p=.98). At 1 week follow-up, more than 80% of women had completed Abortions (77.8% oral and 84.8% sublingual, p=.12). Mean pain scores were 2.95 and 3.04, respectively, for the oral and sublingual groups. Side effects included abdominal pain, bleeding, headaches and dizziness/weakness with no differences reported between the two groups. Acceptability and satisfaction were high for both routes and women indicated a preference for medical versus surgical treatment if ever needed in the future. Conclusions Both treatment regimens were very effective. Four hundred micrograms of sublingual misoprostol and 600 mcg oral misoprostol appear to have similar safety and effectiveness profiles when used for the treatment of Incomplete Abortion. A lower 400-mcg misoprostol dose may provide an alternative treatment option as well as have potential benefits in terms of cost.
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is misoprostol a safe effective and acceptable alternative to manual vacuum aspiration for postAbortion care results from a randomised trial in burkina faso west africa
British Journal of Obstetrics and Gynaecology, 2007Co-Authors: B Dao, Jennifer Blum, Sheila Raghavan, B Thieba, M Ouedraego, J Lankoande, Beverly WinikoffAbstract:Objectives Previous research has demonstrated the effectiveness of misoprostol for treatment of Incomplete Abortion; however, few studies have systematically compared misoprostol’s effectiveness with that of standard surgical care. This study documents the effectiveness of a single 600 micrograms dose of oral misoprostol versus manual vacuum aspiration (MVA) for treatment of Incomplete Abortion in a developing country setting. Design Open-label randomised controlled trial. Setting Two university teaching hospitals in Burkina Faso, West Africa. Population Women of reproductive age presenting with Incomplete Abortion. Methods From April 2004 through October 2004, 447 consenting women with Incomplete Abortion were randomised to either a single dose of 600 micrograms oral misoprostol or MVA for treatment of their condition. Main outcome measure Completed Abortion following initial treatment. Results Regardless of treatment assigned, nearly all participants had a complete uterine evacuation (misoprostol = 94.5%, MVA = 99.1%; relative risk [RR] = 0.95 [95% CI 0.92–0.99]). Acceptability and satisfaction ratings were similar and high for both misoprostol and MVA, with three out of four women indicating that the treatment’s adverse effects were tolerable (misoprostol = 72.9%, MVA = 75.8%; RR = 0.96 [95% CI 0.86–1.07]). The majority of women were ‘satisfied’ or ‘very satisfied’ with the method they received (misoprostol = 96.8%, MVA = 97.7%; RR = 0.99 [95% CI 0.96–1.02]), expressed a desire to choose that method again (misoprostol = 94.5%, MVA = 86.6%; RR = 1.09 [95% CI 1.03–1.16]) and to recommend it to a friend (misoprostol = 94.5%, MVA = 85.2%; RR = 1.11 [95% CI 1.04–1.18]). Conclusion Six hundred micrograms of oral misoprostol is as safe and acceptable as MVA for the treatment of Incomplete Abortion. Operations research is needed to ascertain the role of misoprostol within postAbortion care programmes worldwide.
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misoprostol for treatment of Incomplete Abortion at the regional hospital level results from tanzania
British Journal of Obstetrics and Gynaecology, 2007Co-Authors: B Shwekerela, R Kalumuna, R Kipingili, N Mashaka, E Westheimer, W Clark, Beverly WinikoffAbstract:Objective To investigate the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of Incomplete Abortion. Design A prospective open-label randomised trial. Setting Kagera Regional Hospital, Bukoba, Tanzania. Sample Three hundred women with a clinical diagnosis of Incomplete Abortion and a uterine size <12 weeks. Methods A total of 150 women were randomised to either a single dose of 600 micrograms of oral misoprostol or MVA. If Abortion was clinically complete at 7-day follow up, the woman was released from the study. If it was still Incomplete, the woman was offered the choice of an additional 1-week follow up or immediate MVA. Cases still Incomplete after a further week were offered MVA. Main outcome measures Incidence of successful Abortion (success defined as no secondary surgical intervention provided), incidence of adverse effects, patient satisfaction. Results Success was very high in both arms (misoprostol: 99%; MVA: 100%; difference not significant). Most adverse effects were higher in the misoprostol arm, although the mean pain score was higher in the MVA arm (3.0 versus 3.5; P < 0.001). More women were very satisfied with misoprostol (75%) than with MVA (55%, P= 0.001), and a higher proportion of women in the misoprostol arm said that they would recommend the treatment to a friend (95% versus 75%, P < 0.001). Conclusion Misoprostol is as effective as MVA at treating Incomplete Abortion at uterine size of <12 weeks. The acceptability of misoprostol appears higher. Given the many practical advantages of misoprostol over MVA in low-resource settings, misoprostol should be more widely available for treatment of Incomplete Abortion in the developing world.
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comparison of misoprostol and manual vacuum aspiration for the treatment of Incomplete Abortion
International Journal of Gynecology & Obstetrics, 2007Co-Authors: C Bique, E Westheimer, M Usta, B Debora, E Chong, Beverly WinikoffAbstract:Abstract Objective To compare the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of Incomplete Abortion in Maputo, Mozambique. Methods A total of 270 women with clinically diagnosed Incomplete Abortions of up to 12 weeks of gestation were randomized to either 600 μg oral misoprostol or MVA. Women were followed-up seven days later to evaluate whether the Abortion was complete. Results Success was high for both MVA and misoprostol groups (100% vs 91%, P = 0.002). Women in the MVA arm reported fewer side effects but higher pain scores. Women who received misoprostol were significantly more likely to be “very satisfied” with the treatment and willing to choose the method again. Conclusion Although oral misoprostol was less effective than MVA in this study, it was more acceptable to women. Misoprostol is well-suited for use in low-resource settings, and should be promoted as an option for the treatment of Incomplete Abortion.
Kristina Gemzelldanielsson - One of the best experts on this subject based on the ideXlab platform.
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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
PLOS ONE, 2016Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Amanda Cleeve, Nazarius Mbona Tumwesigye, Kristina Gemzelldanielsson, Elisabeth FaxelidAbstract: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 ...
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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
The Lancet, 2015Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingbergallvin, Amanda Cleeve, Nazarius Mbona Tumwesigye, Elisabeth Faxelid, Kristina GemzelldanielssonAbstract:Summary 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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acceptability of home use of misoprostol in medical Abortion
Contraception, 2004Co-Authors: Christian Fiala, Beverly Winikoff, Lotti Helstrom, Margareta Hellborg, Kristina GemzelldanielssonAbstract:Abstract Introduction Home-use of misoprostol would reduce the number of visits and improve access to medical Abortion. We evaluated acceptance of home-use of misoprostol among women and their partners. Materials and Methods One hundred women with up to 49 days of amenorrhea were given mifepristone, followed by misoprostol taken at home. Results Women chose home-use of misoprostol because it felt more natural, private and allowed the presence of a partner/friend. Two women had a vacuum aspiration due to Incomplete Abortion. Five unscheduled visits occurred. Ninety-six women were satisfied with their choice of home-use. The male partners were generally satisfied with their partner's choice of home-use and felt that their presence and support had been valuable. Discussion Our study shows a high acceptability among women and their partners and confirms the safety and efficacy of home-use of misoprostol. Women should be offered this choice to allow more flexibility and privacy in their Abortions.
Amanda Cleeve - One of the best experts on this subject based on the ideXlab platform.
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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
Trials, 2019Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingbergallvin, Amanda Cleeve, Claudia Hanson, Nazarius Mbona TumwesigyeAbstract: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. 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. 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. ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.
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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
PLOS ONE, 2016Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Amanda Cleeve, Nazarius Mbona Tumwesigye, Kristina Gemzelldanielsson, Elisabeth FaxelidAbstract: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 ...
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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
The Lancet, 2015Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingbergallvin, Amanda Cleeve, Nazarius Mbona Tumwesigye, Elisabeth Faxelid, Kristina GemzelldanielssonAbstract:Summary 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.
Susan Atuhairwe - One of the best experts on this subject based on the ideXlab platform.
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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
Trials, 2019Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingbergallvin, Amanda Cleeve, Claudia Hanson, Nazarius Mbona TumwesigyeAbstract: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. 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. 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. ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.
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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
PLOS ONE, 2016Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Amanda Cleeve, Nazarius Mbona Tumwesigye, Kristina Gemzelldanielsson, Elisabeth FaxelidAbstract: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 ...
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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
The Lancet, 2015Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingbergallvin, Amanda Cleeve, Nazarius Mbona Tumwesigye, Elisabeth Faxelid, Kristina GemzelldanielssonAbstract:Summary 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.
Josaphat Byamugisha - One of the best experts on this subject based on the ideXlab platform.
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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
Trials, 2019Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingbergallvin, Amanda Cleeve, Claudia Hanson, Nazarius Mbona TumwesigyeAbstract: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. 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. 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. ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.
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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
PLOS ONE, 2016Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Amanda Cleeve, Nazarius Mbona Tumwesigye, Kristina Gemzelldanielsson, Elisabeth FaxelidAbstract: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 ...
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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
The Lancet, 2015Co-Authors: Susan Atuhairwe, Josaphat Byamugisha, Marie Klingbergallvin, Amanda Cleeve, Nazarius Mbona Tumwesigye, Elisabeth Faxelid, Kristina GemzelldanielssonAbstract:Summary 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.
