Comparison of vaginal and sublingual misoprostol for second trimester abortion: randomized controlled equivalence trial

Abstract Background A large proportion of abortion-related mortality and morbidity occur 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 Unsafe and outdated methods like sharp curettage are frequently used.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 physician (control arm). Enrolled participants will receive 400mcg of misoprostol administered sublingually 3 hourly up to 5 doses within 24 hours at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 hours 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% CI) and equivalence established if it lies between the pre-defined range of -5% to +5%. Chi-square test will be used for comparison of outcome and t test used to compare mean values. P-values equal to or lower than 0.05 will be considered statistically significant. Conclusions Our study will provide evidence to inform national and international policies, standard care guidelines and training programmes curricula on treatment of second trimester incomplete abortion for improved access.

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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

10.21203/rs.2.131/v1 ◽

2018 ◽

Author(s):

Susan Atuhairwe ◽

Josaphat Byamugisha ◽

Marie Klingberg Allvin ◽

Amanda Cleeve ◽

Claudia Hanson ◽

...

Keyword(s):

Low Income ◽

Second Trimester ◽

Trimester Abortion ◽

Mean Values ◽

Mortality And Morbidity ◽

Equivalence Trial ◽

Randomized Controlled ◽

Incomplete Abortion ◽

Second Trimester Abortion ◽

Safety Effectiveness

Abstract Background: A large proportion of abortion-related mortality and morbidity occur 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 physician (control arm). Enrolled participants will receive 400mcg of misoprostol administered sublingually 3 hourly up to 5 doses within 24 hours at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 hours 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% CI) and equivalence established if it lies between the pre-defined range of -5% to +5%. Chi-square test will be used for comparison of outcome and t test used to compare mean values. P-values equal to or lower than 0.05 will be considered statistically significant. Discussion: Our study will provide evidence to inform national and international policies, standard care guidelines and training programmes curricula on treatment of second trimester incomplete abortion for improved access.

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