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Operative Obstetrics

Poster Session 2

(470) Double-balloon cervical ripening in women with scarred uterus presenting with PROM: A randomized controlled trial

Tuesday, February 13, 2024

3:30 PM – 5:00 PM

Location: Prince George's Exhibit Hall CDE, Lower Atrium Level

Primary & Presenting Author(s)

Gil Gutvirtz, MD

Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Metar, HaDarom, Israel

Coauthor(s)

HB

Hagar Brami, MD

Soroka University Medical Center
Beer-Sheva, Israel
Eyal Sheiner, MD, PhD

Head of department of Obstetrics and Gynecology B, Soroka University Medical Center
Soroka University Medical Center
Beer-Sheva, HaDarom, Israel
Tamar Wainstock, PhD (she/her/hers)

Ben Gurion University
Beer-Sheva, HaDarom, Israel
Omri Zamstein, MD

Soroka University Medical Center
Beer-Sheva, HaDarom, Israel
AW

Asnat Walfisch, MD

Hadassah Mount Scopus
Petach-Tikva, Israel, Israel
Gali Pariente, MD

Acting director of Fetal Maternal Unit B Division of Obstetrics and Gynecology
Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Klahim, HaDarom, Israel

Objective: Women with a scarred uterus who present with pre-labor rupture of membranes (PROM) pose a clinical challenge for labor induction. Using Oxytocin in this setting is associated with an increased risk for uterine rupture. Nevertheless, the insertion of a foreign body following PROM may potentially lead to intra-uterine infection. In this randomized controlled trial, we examine the safety of cervical ripening using a double-balloon catheter in women with a single previous cesarean delivery (CD) who present with PROM and an unfavorable cervix and who opt for trial of labor.

Study Design: In this, NIH registered, prospective randomized controlled trial, women with a previous CD, who presented with PROM and an unfavorable cervix were randomly allocated following maternal consent to either cervical ripening with a double-balloon catheter or to expectant management. The double-balloon catheter was placed for 12 hours or until spontaneously expelled. After balloon expulsion or removal, an identical expectant management protocol was followed in both groups. The primary outcome was maternal or neonatal infection rates. Secondary outcomes included successful vaginal birth after cesarean (VBAC) rates and time-to-delivery interval. Multivariable analyses were used to control for confounders.

Results: A total of 60 women were included in the study, 32 were allocated to the intervention group and 28 to expectant management. Rates of maternal infections and VBAC were comparable between the groups (Table). No cases of uterine rupture or neonatal infections were noted in either group. Time-to-delivery was significantly shorter in the intervention group (Table). A multivariable linear regression model, controlled for parity, proved cervical ripening with a double-balloon catheter to significantly reduce PROM-to-delivery interval (Table).

Conclusion: Cervical ripening with a double-balloon catheter appears to be safe in the setting of ruptured membranes. For women with a scarred uterus, PROM, and an unfavorable cervix, such intervention reduces time-to-delivery interval with no apparent increase in adverse outcomes.