Biomaterial Database

Mifepristone for preinduction cervical ripening beyond 41 weeks' gestation: a randomized controlled trial. 2000

D A Wing, and M J Fassett, and D R Mishell

Department of Obstetrics-Gynecology, Division of Maternal-Fetal Medicine, Women's & Children's Hospital, Keck School of Medicine of the University of Southern California, Los Angeles, California 90033, dwing@hsc.usc.edu

OBJECTIVE To compare the effect of mifepristone with placebo on cervical ripening before labor induction in prolonged pregnancies. METHODS One hundred eighty women with pregnancies beyond 41 weeks and undilated, uneffaced cervices were assigned randomly to receive mifepristone 200 mg or placebo and observed for 24 hours. We then gave intravaginal misoprostol 25 microg every 4 hours or intravenous oxytocin. We expected 60% of placebo-treated and 80% of mifepristone-treated women to deliver vaginally within 48 hours. RESULTS Among 180 subjects, 97 received mifepristone and 83 received placebo. The mean interval (+/- standard deviation [SD]) from start of induction to delivery was 2209 +/- 698 minutes for mifepristone-treated subjects and 2671 +/- 884 minutes for placebo-treated subjects (P <.001, log-transformed data). Twelve (13. 6%) mifepristone-treated women and seven (10.8%) placebo-treated women delivered vaginally on day 1 (P =.60). After 24 hours, the median Bishop score for both groups was 3 (0-11) (P =.51). One hundred thirty-one subjects required misoprostol, 65 (67.0%) were mifepristone-treated women, and 66 (79.5%) placebo-treated women (P =.06). The median (range) oxytocin dose was 871.5 (0-22,174) mU for mifepristone-treated women and 2021.0 (0-24,750) mU for placebo-treated women (P =.02). Seventy-seven (87.5%) mifepristone-treated women and 46 (70.8%) placebo-treated women delivered vaginally 48 hours after the start of treatment (P =.01). There were nine cesareans in the mifepristone group and 18 in the placebo group (P =.02). More nonreassuring fetal heart rate patterns and uterine contractile abnormalities occurred in mifepristone-treated subjects. There were no statistically significant differences in neonatal outcomes between groups. CONCLUSIONS Mifepristone had a modest effect on cervical ripening when given 24 hours before labor induction, appearing to reduce the need for misoprostol and oxytocin compared with placebo.

UI	MeSH Term	Description	Entries
D007751	Labor, Induced	Artificially induced UTERINE CONTRACTION.	Induced Labor,Induction of Labor,Labor Induced,Labor Induction,Induced, Labor,Induction, Labor,Inductions, Labor,Labor Inductions
D010120	Oxytocics	Drugs that stimulate contraction of the myometrium. They are used to induce LABOR, OBSTETRIC at term, to prevent or control postpartum or postabortion hemorrhage, and to assess fetal status in high risk pregnancies. They may also be used alone or with other drugs to induce abortions (ABORTIFACIENTS). Oxytocics used clinically include the neurohypophyseal hormone OXYTOCIN and certain prostaglandins and ergot alkaloids. (From AMA Drug Evaluations, 1994, p1157)	Oxytocic,Oxytocic Agent,Oxytocic Drug,Uterine Stimulant,Uterine Stimulants,Oxytocic Agents,Oxytocic Drugs,Oxytocic Effect,Oxytocic Effects,Agent, Oxytocic,Agents, Oxytocic,Drug, Oxytocic,Drugs, Oxytocic,Effect, Oxytocic,Effects, Oxytocic,Stimulant, Uterine,Stimulants, Uterine
D010121	Oxytocin	A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION.	Ocytocin,Pitocin,Syntocinon
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
D011273	Pregnancy, Prolonged	A term used to describe pregnancies that exceed the upper limit of a normal gestational period. In humans, a prolonged pregnancy is defined as one that extends beyond 42 weeks (294 days) after the first day of the last menstrual period (MENSTRUATION), or birth with gestational age of 41 weeks or more.	Prolonged Pregnancy,Pregnancies, Prolonged,Prolonged Pregnancies
D002585	Cesarean Section	Extraction of the FETUS by means of abdominal HYSTEROTOMY.	Abdominal Delivery,Delivery, Abdominal,C-Section (OB),Caesarean Section,Postcesarean Section,Abdominal Deliveries,C Section (OB),C-Sections (OB),Caesarean Sections,Cesarean Sections,Deliveries, Abdominal
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
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328	Adult	A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available.	Adults