David A Grimes1, M Susan Smith, Angela D Witham. 1. Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
Abstract
OBJECTIVE: To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion. DESIGN: Pilot randomised controlled trial. SETTING: University of North Carolina Hospitals, Chapel Hill, North Carolina. POPULATION: Women aged 18 years or older and without prior uterine operations who requested abortion at 14-19 menstrual weeks of gestation from January 2002 to January 2003. METHODS: Participants received either mifepristone 200 mg by mouth followed in two days by vaginal then oral misoprostol (Aberdeen regimen) or D&E after one or two days of laminaria preparation. Care was provided by residents under faculty supervision. MAIN OUTCOME MEASURES: Enrolment rate and acceptability of and adverse events associated with methods. RESULTS: The trial was stopped at one year because of slow enrolment. Of 47 women eligible for the trial, 29 (62%) declined participation, primarily because of a preference for D&E abortion. Among the 18 participants enrolled, nine were randomised to treatment with mifepristone-misoprostol and 9 to D&E. Compared with D&E, mifepristone-misoprostol abortion caused more pain and adverse events, although none was serious. CONCLUSIONS: Our findings concerning acceptability and adverse events should be considered hypothesis-generating; they may prove useful in planning a larger randomised controlled trial. Such a trial will be difficult to mount in the US. Hence, we suggest that it be done in a setting where labour-induction abortion is the norm.
RCT Entities:
OBJECTIVE: To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion. DESIGN: Pilot randomised controlled trial. SETTING: University of North Carolina Hospitals, Chapel Hill, North Carolina. POPULATION: Women aged 18 years or older and without prior uterine operations who requested abortion at 14-19 menstrual weeks of gestation from January 2002 to January 2003. METHODS:Participants received either mifepristone 200 mg by mouth followed in two days by vaginal then oral misoprostol (Aberdeen regimen) or D&E after one or two days of laminaria preparation. Care was provided by residents under faculty supervision. MAIN OUTCOME MEASURES: Enrolment rate and acceptability of and adverse events associated with methods. RESULTS: The trial was stopped at one year because of slow enrolment. Of 47 women eligible for the trial, 29 (62%) declined participation, primarily because of a preference for D&E abortion. Among the 18 participants enrolled, nine were randomised to treatment with mifepristone-misoprostol and 9 to D&E. Compared with D&E, mifepristone-misoprostol abortion caused more pain and adverse events, although none was serious. CONCLUSIONS: Our findings concerning acceptability and adverse events should be considered hypothesis-generating; they may prove useful in planning a larger randomised controlled trial. Such a trial will be difficult to mount in the US. Hence, we suggest that it be done in a setting where labour-induction abortion is the norm.
Authors: Daniel Grossman; Deborah Constant; Naomi Lince; Marijke Alblas; Kelly Blanchard; Jane Harries Journal: BMC Health Serv Res Date: 2011-09-19 Impact factor: 2.655
Authors: Marike Lemmers; Marianne Ac Verschoor; Bobae Veronica Kim; Martha Hickey; Juan C Vazquez; Ben Willem J Mol; James P Neilson Journal: Cochrane Database Syst Rev Date: 2019-06-17
Authors: Jay Ghosh; Argyro Papadopoulou; Adam J Devall; Hannah C Jeffery; Leanne E Beeson; Vivian Do; Malcolm J Price; Aurelio Tobias; Özge Tunçalp; Antonella Lavelanet; Ahmet Metin Gülmezoglu; Arri Coomarasamy; Ioannis D Gallos Journal: Cochrane Database Syst Rev Date: 2021-06-01