NCT02801227

Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop

Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop Score: Randomized Control Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding time from induction of labor (IOL) to delivery among primiparas at term with prelabor rupture of membrane (PROM) and an unfavorable cervix.

Detailed description

The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding time from induction of labor (IOL) to delivery among primiparas at term with prelabor rupture of membrane (PROM) and an unfavorable cervix. Our secondary outcome is to compare between the groups regarding obstetric complications including: cesarean delivery, operative vaginal delivery, maternal intrapartum fever, postpartum hemorrhage, Apgar score at 5 minutes ≤ 7, PH, admission to NICU and the time from initiation of induction to active labor. The study population will include primiparous at term with PROM and unfavorable bishop score (≤3). Subsequent to confirming inclusion criteria and after receiving informed consent parturients will be randomly allocated to receive oxytocin or PGE2. Induction with oxytocin (group 1) will be initiated by infusion of intravenous oxytocin: 2.5 mIU per minute with increments of 2.5 mIU every 20 minutes until achieving 4-5 contractions during 10 minutes. Then after continuous infusion without increasing oxytocin dose will be continued. In case of lack of painful contraction/active labor after 24 hours with oxytocin a trial with PGE2 will be initiated (as described for group 2) Induction with PGE2 (group 2) will be initiated by inserting to the posterior fornix PGE2 2 mg, this will be repeated every 6 hours until achieving painful contractions or up to 4 doses (24 hours). In case of lack of painful contraction/active labor after the fourth dose of PGE2 a trial with oxytocin will be initiated (as described for group1). Failed induction will be defined for parturients who failed to develop active labor after 48 hours from initiation of induction. Decisions regarding management of labor including all aspects of labor (augmentation, delivery, postpartum) will be made by the physician in charge and will be based on standards of our labor room.

Conditions

• Premature Rupture of Fetal Membranes

Interventions

Type	Name	Description
DRUG	Oxytocin	Intravenous oxytocin: 2.5 mIU per minute with increments of 2.5 mIU every 20 minutes until achieving 4-5 contractions during 10 minutes or 20 mIU. Then after continuous infusion without increasing oxytocin dose will be continued. In case of lack of painful contraction/active labor after 24 hours with oxytocin a trial with PGE2 will be initiated (as described for PGE2)
DRUG	Prostaglandin E2	PGE2 2 mg wil be inserted to the posterior fornix, this will be repeated every 6 hours until achieving painful contractions or up to 4 doses (24 hours). In case of lack of painful contraction/active labor after the fourth dose of PGE2 a trial with oxytocin will be initiated (as described for Oxytocin).

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-06-15
• Last updated: 2016-06-15