Clinical trial NCT02098421: Foley Labor Induction Trial at Term and in PROM
Official title: A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Induction of Labor
Keywords: Induction of Labor
Pitocin
Oxytocin
Foley bulb
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 312
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: induction time to delivery
timeFrame: Time from induction to delivery, average 12-28 hours
Secondary outcomes:
measure: Mode of delivery
timeFrame: average of 12-28 hours from induction until official time of birth
measure: estimated blood loss
timeFrame: average of 12-28 hours from induction until official time of birth
measure: uterine atony
timeFrame: average of 12-28 hours from induction until official time of birth
measure: chorioamnionitis
timeFrame: average of 12-28 hours from induction until official time of birth
measure: neonatal birthweight
timeFrame: average of 12-28 hours from induction until official time of birth
Other outcomes:
Locations:
city: Elmhurst
country: United States
facility: Elmhurst Hospital Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Angela Bianco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Connolly KA, Kohari KS, Factor SH, Rekawek P, Miller MR, Smilen BS, Stone JL, Bianco AT. A Randomized Trial of Foley Balloon Induction of Labor Trial in Multiparas (FIAT-M). Am J Perinatol. 2017 Sep;34(11):1108-1114. doi: 10.1055/s-0037-1603994. Epub 2017 Jun 26. No abstract available.