[The value of RU-486 (mifepristone) in medical indications of the induction of labor at term. Results of a double-blind randomized prospective study (RU-486 versus placebo)]. 1993

C Lelaidier, and J L Benifla, and H Fernandez, and C Baton, and P Bourget, and M C Bourrier, and R Frydman
Service de Gynécologie-Obstétrique, Hôpital Antoine-Béclère, Clamart.

One hundred and twenty term women (> 37.5 weeks amenorrhea) with unripe cervixes (Bishop < 4) and with a clear clinical indication for labour induction were randomized to receive either mifepristone (RU 486) or placebo. The patients' regimens consisted of 200 mg of mifepristone on days 1 and 2 over an observation period of 4 days, with labour induction planned for day 4. Within 12 hours after taking the first tablet, fetal distress was diagnosed in 8 patients (3 in the Mifepristone group and 5 in the control group), who underwent immediate cesarean section. These 8 patients could not therefore participate in our survey and have been excluded from the final results. Forty one patients had spontaneous onset of labour, 31 in the mifepristone group and 10 in the control group (p < 0.001). Forty seven patients needed cervical maturation with prostaglandin, 32 from the control group and 13 from the mifepristone group (p < 0.001). Thirteen patients in each group had cervical maturation sufficient for classical labour induction. We noted that patients delivering vaginally needed significantly lower amount of oxytocin in the mefepristone group and that the mean time interval between day 1 and the onset of labour was also significantly shorter in this group. The high cesarean section rate (32%), which is equivalent in both the placebo and the treated groups, may be attributed to the fact most of the patients in this survey had high risk pregnancies. There was no difference in the occurrence of fetal distress during labour in the 2 groups. Neonatal parameters were similar in both groups. These results establish mifepristone as an induction agent for the initiation of labour in term women. Though more studies are needed, Mifepristone has shown itself to be safe and appropriate in situations where labor has to be induced in term women.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
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
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
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
D011256 Pregnancy Outcome Results of conception and ensuing pregnancy, including LIVE BIRTH; STILLBIRTH; or SPONTANEOUS ABORTION. The outcome may follow natural or artificial insemination or any of the various ASSISTED REPRODUCTIVE TECHNIQUES, such as EMBRYO TRANSFER or FERTILIZATION IN VITRO. Outcome, Pregnancy,Outcomes, Pregnancy,Pregnancy Outcomes
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D002584 Cervix Uteri The neck portion of the UTERUS between the lower isthmus and the VAGINA forming the cervical canal. Cervical Canal of the Uterus,Cervical Canal, Uterine,Ectocervix,Endocervical Canal,Endocervix,External Os Cervix,External Os of the Cervix,Uterine Cervical Canal,Cervix,Cervixes,Uterine Cervix,Canal, Endocervical,Canal, Uterine Cervical,Cervix, External Os,Cervix, Uterine,Endocervical Canals,Uterine Cervical Canals
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

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