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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2017

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • Experimental: Oxytocin
  • Experimental: Prostaglandin E2

Clinical Trial Outcome Measures

Primary Measures

  • Time from induction of labor to delivery comparing between oxytocin and PGE2 among primiparas with prelabor rupture of membrane at term and low Bishop score (≤ 3) regarding the time needed to complete a vaginal delivery.
    • Time Frame: up to 48 hours

Secondary Measures

  • cesarean delivery
    • Time Frame: 3 dyas
  • operative vaginal delivery
    • Time Frame: 3 dyas
  • maternal intrapartum fever
    • Time Frame: one week
  • postpartum hemorrhage
    • Time Frame: 3 dyas
  • Apgar score at 5 minutes ≤ 7
    • Time Frame: 3 days
  • admission to NICU
    • Time Frame: a week

Participating in This Clinical Trial

Inclusion Criteria

Age 18-38 years Primiparas Term (37-42) EFW 2500-4000 PROM < 12 hours Confirmed PROM No painful contractions Vertex presentation Willing to be induced Bishop score: (3 or less) cervix: elongated, posterior, closed, firm-medium, head SP-1 or higher Exclusion Criteria:

Intrauterine growth retardation preterm<37 weeks painful contraction Other reasons for induction aside from PROM as: severe PIH, uncontrolled GDM Medical conditions that the researcher thinks will affect the outcome -

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shaare Zedek Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Orna Reichman, Dr. Orna Reichman MD MSCE – Shaare Zedek Medical Center
  • Overall Official(s)
    • Orna Reichman, MD, Principal Investigator, Shaare Zedek Medical Center
  • Overall Contact(s)
    • Orna Reichman, MD, orna.reich@gmail.com

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