Premature Rupture of Fetal Membranes Clinical Trial
Official title:
Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop Score: Randomized Control Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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