Foley Labor Induction Trial at Term and in PROM
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/20/2016 |
| Start Date: | November 2014 |
| End Date: | April 2017 |
| Contact: | Meredith Miller, MPH |
| Email: | meredith.miller@mssm.edu |
| Phone: | 212-241-3888 |
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).
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.
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.
Inclusion Criteria:
- women at > 24 weeks gestation
- a non-anomalous, singleton fetus in a vertex presentation
Exclusion Criteria:
- history of prior uterine surgery such as cesarean section or myomectomy
- unexplained vaginal bleeding
- latex allergy
- contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active
vaginal bleeding, macrosomia etc)
We found this trial at
2
sites
Elmhurst, New York 11373
Principal Investigator: Laura Ferrara, MD
Phone: 718-334-5366
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1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Angela Bianco, MD
Phone: 212-241-6840
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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