Balloon cervical ripening with extra-amniotic infusion of saline or prostaglandin E2: a double-blind, randomized controlled study.
OBJECTIVE
To compare extra-amniotic infusion of diluted prostaglandin (PG) E2 solution with saline infusion in balloon cervical ripening and labor induction.


METHODS
Women with pregnancy complications and Bishop scores of 3 or lower (n = 116) were assigned randomly to receive extra-amniotic infusion (1 mL/minute) of normal saline or PGE2 in saline (0.5 microg/mL) through a Foley catheter with a 30-mL inflated balloon. We induced labor using intravenous oxytocin only when labor had not developed by 6 hours after balloon expulsion. Analysis was by intent-to-treat. We assessed ripening efficiency and course of labor in women who had spontaneous balloon expulsion (n = 110) and trial of labor (n = 107), respectively.


RESULTS
Ripening with PGE2 was associated with significantly shorter mean (+/- standard error of the mean [SEM]) time for balloon expulsion (4.7 +/- 0.4 versus 6.5 +/- 0.6 hours) and with significantly higher Bishop scores (P <.002), compared with ripening with saline. In the PGE2 group, rates of labor induction (15%) and oxytocin use (37%) were significantly lower than in the saline group (51% and 72%, respectively). The groups did not differ significantly in other labor abnormalities, labor duration, mode of delivery, birth weight, Apgar scores, and puerperal morbidity.


CONCLUSIONS
Cervical ripening by extra-amniotic balloon and PGE2 infusion is faster and more effective than by balloon and saline infusion, resulting in a higher rate of spontaneous labor and a lower rate of oxytocin use.
Sherman
D J
DJ
Department of Obstetrics and Gynecology, Assaf Harofeh Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. dsherman@netvision.net.il
Frenkel
E
E
Pansky
M
M
Caspi
E
E
Bukovsky
I
I
Langer
R
R
D000328:Adult; D000653:Amniotic Fluid; D002404:Catheterization; D020070:Cervical Ripening; D015232:Dinoprostone / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007751:Labor, Induced; D010120:Oxytocics / Q000008:administration & dosage*; D011247:Pregnancy; D012965:Sodium Chloride / Q000008:administration & dosage*
D010120:Oxytocics; D012965:Sodium Chloride; D015232:Dinoprostone