A randomized controlled trial of 24-hour vaginal dinoprostone pessary compared to gel for induction of labor in term pregnancies with a Bishop score < or = 4.
OBJECTIVE
To compare 24-hour controlled-release vaginal dinoprostone pessary vs. gel for induction of labor at term in women with an unfavorable cervix.


METHODS
Randomized controlled trial.


METHODS
University hospital.


METHODS
A total of 133 women with singleton pregnancies, fetal cephalic presentation, Bishop score < or = 4, gestational age of 37-42 weeks, no previous cesarean section and intact membranes admitted for induction of labor.


METHODS
Random allocation to either 24-hour 10-mg controlled-release vaginal dinoprostone pessary or repeat doses of 2 mg vaginal dinoprostone gel.


METHODS
Rate of spontaneous vaginal, operative vaginal and cesarean delivery.


RESULTS
The rate of spontaneous vaginal delivery was significantly higher in the pessary group (72%) than in the gel group (54%), paralleled by a lower rate of operative vaginal deliveries (3 vs. 15%). The difference in cesarean section rate (25 vs. 31%) did not reach statistical significance. Both methods of induction of labor appeared to be safe, with no cases of 5-minute Apgar scores < 7 or episodes of uterine hyperstimulation in either group. The medication cost was lower in the pessary group, with a median saving of 50.20 euro compared to the gel group.


CONCLUSIONS
Both the 24-hour dinoprostone vaginal pessary and the vaginal gel appear to be safe for labor induction. In women induced at term with a Bishop score < or = 4 the pessary achieved a significantly higher rate of spontaneous vaginal delivery.
Triglia
Maria Teresa
MT
Maternal-Fetal Medicine Unit, Department of Obstetrics and Gynaecology, University of Brescia, Piazzale Spedali Civili 1, Brescia, Italy.
Palamara
Fabrizio
F
Lojacono
Andrea
A
Prefumo
Federico
F
Frusca
Tiziana
T
D000282:Administration, Intravaginal; D000328:Adult; D020070:Cervical Ripening / Q000187:drug effects*; D016009:Chi-Square Distribution; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D015232:Dinoprostone / Q000008:administration & dosage*; D005260:Female; D005865:Gestational Age; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D010120:Oxytocics / Q000008:administration & dosage*; D010570:Pessaries; D011247:Pregnancy; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D012016:Reference Values; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D047929:Term Birth; D014622:Vaginal Creams, Foams, and Jellies
D003692:Delayed-Action Preparations; D010120:Oxytocics; D014622:Vaginal Creams, Foams, and Jellies; D015232:Dinoprostone