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Oral Concurrent Session 8 - Labor & Delivery

Oral Concurrent Sessions

(77) Early or late Amniotomy Following Extra-Amniotic-Balloon Cervical Ripening: a Multicenter Randomized Controlled Trail

Wednesday, February 14, 2024

3:30 PM - 3:45 PM

Location: Potomac Ballroom C, Ballroom Level

Primary & Presenting Author(s)

Atara De Porto, MD (she/her/hers)

Resident
Assuta Ashdod Medical Center
Ashdod, HaDarom, Israel

Coauthor(s)

Ep

Elad proiss, MD

Assuta Ashdod Medical Center
Ashdod, HaDarom, Israel
RH

Rina Hagege, MD

Samson Assuta Ashdod University Hospital
Ashdod, HaDarom, Israel
ST

Sarit Tetro, MD

Assuta Ashdod Medical Center
Ashdod, HaDarom, Israel
YT

Yosef Tovbin, MD

Assuta Ashdod Medical Center
Ashdod, HaDarom, Israel
EB

Eran Barzilay, MD, PhD

Head of Ultrasound unit
Assuta Ashdod University Hospital, Ben Gurion University of the Negev
Ashdod, Israel, Israel
Enav Yefet, MD, PhD

Tzafon Medical Center
Afula, HaZafon, Israel
NS

Natalia Seledets, MD

Tzafon medical center, Poriya, Israel
Poria, HaZafon, Israel
Dana Vitner, MD

Rambam Medical Health Campus
Toronto, ON, Canada
HR

Hadar Rosen, MD

Fetal Medicine specialist
Sheba Medical Center, Tel Hashomer
Toronto, Ontario, Canada
EW

Eran Weiner, MD

Department head
Wolfson Medical Center
Tel Aviv, HaMerkaz, Israel
YG

Yael Ganor Paz, MD

Senior physician
Edith Wolfson Medical Center
Shoham, HaMerkaz, Israel

Objective:

Extra amniotic balloon (EAB) is a widespread mechanical method for cervical ripening. Following EAB the clinician may choose the method for induction of labor - either artificial rupture of membranes or oxytocin infusion, delaying amniotomy to a later stage of labor. We aimed to examine the effectiveness of early versus late amniotomy following balloon cervical ripening for labor induction at term.

Study Design:

A prospective, multi center randomized controlled trial included patients underwent labor induction , using an EAB for cervical ripening. Patients were randomly assigned to two groups based on the primary intervention: Early amniotomy group, in which amniotomy was performed as the primary intervention. Oxytocin infusion was begun no earlier than 2 hours following amniotomy. For the late amniotomy group oxytocin infusion was begun as per local protocol. Amniotomy was performed no earlier than 2 hours following commence of oxytocin infusion.

Included were patients at 37-42 weeks gestational age, singleton pregnancy, vertex presentation and medical indication for labor induction. Exclusion criteria included multiple pregnancies, preterm pregnancy, previous cesarean section and uterine malformation.

Primary outcome was interval from primary intervention to delivery. Secondary outcomes were intrapartum and neonatal fever.

Results:

Of 146 eligible patients, 72 had early amniotomy as primary intervention and 72 had oxytocin infusion. There was no significant difference between groups in the rate of primiparous patients, achieved Bishop score , or management not by intention to treat. Time to delivery was significantly shorter among patients in the early amniotomy group (15.6 hours (range 9.8-26.9) VS 11.8 hours (range 7-17.7), P=0.025). This difference was significant for intervention to delivery interval above 18 hours, but not longer then 24 hours (Figure).There was no difference in the rate of intrapartum or neonatal fever.

Conclusion: After EAB ripening, opting for an early rupture of membranes to induce labor enhances the likelihood of labor occurring within 24 hours of induction.