Induction of Labor Clinical Trial
Official title:
A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
This study is considering current standard oxytocin dosing regimen in combination with Foley
bulb for cervical ripening is associated with improved outcomes including greater percentage
of women delivered within or less than 24 hours. The investigators will also assess other
maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis),
bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or
no oxytocin while the Foley bulb is in place. As part of standard of care for inductions,
Foley bulbs will be placed for all participants. Study participants who are randomly
assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed.
Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley
bulb is removed.
After delivery, information will be collected from participant's chart on the outcome of
pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean
section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk. ;
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