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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms

  • Fetal Membranes, Premature Rupture
  • Medical Induction of Labor Affecting Newborn
  • Rupture

NCT number NCT02825641
Study type Interventional
Source Rambam Health Care Campus
Contact
Status Completed
Phase N/A
Start date August 1, 2016
Completion date September 30, 2022