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Foley Labor Induction Trial at Term and in PROM

Mount Sinai Health System logo

Mount Sinai Health System

Status and phase

Completed
Phase 1

Conditions

Induction of Labor

Treatments

Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT02098421
GCO 13-1279

Details and patient eligibility

About

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).

Full description

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.

Enrollment

312 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

312 participants in 4 patient groups

Control
No Intervention group
Description:
No oxytocin while the Foley bulb is in place
Oxytocin
Experimental group
Description:
Use of oxytocin while the Foley bulb is in place
Treatment:
Drug: Oxytocin
PROMS Foley and oxytocin
Experimental group
Description:
Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.
Treatment:
Drug: Oxytocin
PROMS no Foley bulb
No Intervention group
Description:
Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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