Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop
Primary Purpose
Premature Rupture of Fetal Membranes
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxytocin
Prostaglandin E2
Sponsored by
About this trial
This is an interventional treatment trial for Premature Rupture of Fetal Membranes focused on measuring premature rupture of membrane, primipara, term, bishop
Eligibility Criteria
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
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oxytocin
Prostaglandin E2
Arm Description
Outcomes
Primary Outcome 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.
Secondary Outcome Measures
cesarean delivery
operative vaginal delivery
maternal intrapartum fever
postpartum hemorrhage
Apgar score at 5 minutes ≤ 7
admission to NICU
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02801227
Brief Title
Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop
Official Title
Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop Score: Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Rupture of Fetal Membranes
Keywords
premature rupture of membrane, primipara, term, bishop
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Title
Prostaglandin E2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Prostaglandin E2
Intervention Description
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).
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
cesarean delivery
Time Frame
3 dyas
Title
operative vaginal delivery
Time Frame
3 dyas
Title
maternal intrapartum fever
Time Frame
one week
Title
postpartum hemorrhage
Time Frame
3 dyas
Title
Apgar score at 5 minutes ≤ 7
Time Frame
3 days
Title
admission to NICU
Time Frame
a week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orna Reichman, MD
Email
orna.reich@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orna Reichman, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop
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