Prostaglandin E vaginal gel to treat dystocia in spontaneous labour: a multicentre randomised placebo-controlled trial.
OBJECTIVE
To test the safety and efficacy of prostaglandin E(2) (PgE(2)) as a treatment for dystocia in spontaneous labour.


METHODS
Randomised, double-blind, placebo-controlled trial.


METHODS
Multicentre study in nine university-affiliated hospitals in Canada. Population Three hundred and thiry-two nulliparous women with spontaneous labour at term.


METHODS
Women who had progressed < 2 cm of cervical dilation in the 4 hours following the diagnosis of labour were randomly assigned to receive a single dose of either 1 mg (n= 112) or 2 mg (n= 111) PgE(2) vaginal gel or placebo gel (n= 109).


METHODS
The primary outcome was resolution of dystocia, defined as a change in cervical dilatation of >0.5 cm per hour in the 6 hours following gel administration. Secondary outcomes were progress of labour, uterine hyperstimulation (more than five contractions in 10 minutes or a contraction lasting more than 2 minutes), use of oxytocin, method of delivery, maternal and neonatal morbidity.


RESULTS
Dystocia resolved more often after PgE(2) 1 mg (49%), RR 1.53 (95% CI 1.1, 2.1) and PgE(2) 2 mg (49%), RR 1.5 (CI 1.1, 2.1), compared with placebo (32%). Hyperstimulation was increased after PgE(2) 2 mg treatment (15%), RR 5.6 (95% CI 1.7, 18), but not after PgE(2) 1 mg (5.4%), RR 1.9 (CI 0.50, 7.6) when compared with placebo (2.8%). There was an increase in caesarean sections performed in the second stage of labour in the PgE(2) groups versus placebo. There were no differences in measures of maternal or neonatal morbidity.


CONCLUSIONS
A single 1-mg dose of PgE(2) vaginal gel is more effective than placebo in resolving dystocia, without increasing uterine hyperstimulation, but may be associated with an increase in the incidence of second stage caesarean section.
Oppenheimer
Lawrence W
LW
Department of Obstetrics and Gynaecology, University of Ottawa, Ottawa Hospital-General Campus, Rm. 8420, Ottawa, Ontario, Canada K1H 8L6.
Labrecque
Michel
M
Wells
George
G
Bland
Elaine S
ES
Fraser
William D
WD
Eason
Erica
E
Brisson-Carroll
Gisele
G
Yetisir
Elizabeth
E
D000328:Adult; D015232:Dinoprostone; D004311:Double-Blind Method; D004420:Dystocia / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007745:Labor Onset; D007747:Labor Stage, First; D010120:Oxytocics; D011247:Pregnancy; D011256:Pregnancy Outcome; D014622:Vaginal Creams, Foams, and Jellies
D010120:Oxytocics; D014622:Vaginal Creams, Foams, and Jellies; D015232:Dinoprostone