Foley Labor Induction Trial at Term and in PROM

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.