The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes. The means of labor induction and cervical ripening are either oxytocin or dinoprostone. Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition. The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.
In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions. The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections. The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone. The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery. Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
458
Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes.
Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes.
Rambam health care campus
Haifa, Israel
Vaginal delivery rate
The percentage of participants that achieved vaginal delivery
Time frame: Up to 7 days from the time of presentation with rupture of membranes
Interval to delivery
Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)
Time frame: Up to 7 days from the time of presentation with rupture of membranes
Caesarian delivery rate
The percentage of participants that required caesarian delivery
Time frame: Up to 7 days from the time of presentation with rupture of membranes
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