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Balloon Cervical Ripening With Extra-Amniotic Infusion of Saline or Prostaglandin E₂: A Double-Blind, Randomized Controlled Study

From the Department of Obstetrics and Gynecology, Assaf Harofeh Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

Address reprint requests to: Dan J. Sherman, MD, Department of Obstetrics and Gynecology, Assaf Harofeh Medical Center, 70300 Zerifin, Israel, E-mail: dsherman{at}netvision.net.il

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 µg/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.

Conclusion: 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.

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				M. G. Lin, K. J. Reid, M. R. Treaster, F. S. Nuthalapaty, P. S. Ramsey, and G. C. Lu Transcervical Foley Catheter With and Without Extraamniotic Saline Infusion for Labor Induction: A Randomized Controlled Trial Obstet. Gynecol., September 1, 2007; 110(3): 558 - 565. [Abstract] [Full Text] [PDF]