Mifepristone and misoprostol versus dilation and evacuation for midtrimester abortion: a pilot randomised controlled trial. 2004

David A Grimes, and M Susan Smith, and Angela D Witham
Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.

OBJECTIVE To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion. METHODS Pilot randomised controlled trial. METHODS University of North Carolina Hospitals, Chapel Hill, North Carolina. METHODS 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. METHODS 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.

UI MeSH Term Description Entries
D010865 Pilot Projects Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work. Pilot Studies,Pilot Study,Pilot Project,Project, Pilot,Projects, Pilot,Studies, Pilot,Study, Pilot
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011262 Pregnancy Trimester, Second The middle third of a human PREGNANCY, from the beginning of the 15th through the 28th completed week (99 to 196 days) of gestation. Midtrimester,Pregnancy, Second Trimester,Trimester, Second,Midtrimesters,Pregnancies, Second Trimester,Pregnancy Trimesters, Second,Second Pregnancy Trimester,Second Pregnancy Trimesters,Second Trimester,Second Trimester Pregnancies,Second Trimester Pregnancy,Second Trimesters,Trimesters, Second
D004107 Dilatation and Curettage Dilatation of the cervix uteri followed by a scraping of the endometrium with a curette. Curettage and Dilatation,Dilatation & Curettage
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004359 Drug Therapy, Combination Therapy with two or more separate preparations given for a combined effect. Combination Chemotherapy,Polychemotherapy,Chemotherapy, Combination,Combination Drug Therapy,Drug Polytherapy,Therapy, Combination Drug,Chemotherapies, Combination,Combination Chemotherapies,Combination Drug Therapies,Drug Polytherapies,Drug Therapies, Combination,Polychemotherapies,Polytherapies, Drug,Polytherapy, Drug,Therapies, Combination Drug
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000019 Abortifacient Agents Chemical substances that interrupt pregnancy after implantation. Abortifacient Effect,Abortifacient Effects,Abortifacients,Contraceptive Agents, Postconception,Agents, Abortifacient,Agents, Postconception Contraceptive,Effect, Abortifacient,Effects, Abortifacient,Postconception Contraceptive Agents
D000020 Abortifacient Agents, Nonsteroidal Non-steroidal chemical compounds with abortifacient activity. Abortifacient Agents, Non-Steroidal,Abortifacient Agents, Non Steroidal,Agents, Non-Steroidal Abortifacient,Agents, Nonsteroidal Abortifacient,Non-Steroidal Abortifacient Agents,Nonsteroidal Abortifacient Agents

Related Publications

David A Grimes, and M Susan Smith, and Angela D Witham
September 2010, BJOG : an international journal of obstetrics and gynaecology,
David A Grimes, and M Susan Smith, and Angela D Witham
February 1981, American journal of obstetrics and gynecology,
David A Grimes, and M Susan Smith, and Angela D Witham
April 2007, Obstetrics and gynecology,
David A Grimes, and M Susan Smith, and Angela D Witham
December 2017, BJOG : an international journal of obstetrics and gynaecology,
David A Grimes, and M Susan Smith, and Angela D Witham
June 2006, BJOG : an international journal of obstetrics and gynaecology,
David A Grimes, and M Susan Smith, and Angela D Witham
September 2011, Obstetrics and gynecology,
David A Grimes, and M Susan Smith, and Angela D Witham
February 2010, Contraception,
Copied contents to your clipboard!