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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Rupture of Fetal Membranes

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Prostaglandin E2


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br> | Drug: Oxytocin<br>* 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)<br>|
| Experimental: Prostaglandin E2<br> | Drug: Prostaglandin E2<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cesarean delivery |  | 3 dyas | 
| operative vaginal delivery |  | 3 dyas | 
| maternal intrapartum fever |  | one week | 
| postpartum hemorrhage |  | 3 dyas | 
| Apgar score at 5 minutes ≤ 7 |  | 3 days | 
| admission to NICU |  | a week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature rupture of membrane, primipara, term, bishop