NCT02098421

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2016

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

March 13, 2014

Last Update Submit

June 9, 2017

Conditions

Induction of Labor

Keywords

Induction of LaborPitocinOxytocinFoley bulb

Outcome Measures

Primary Outcomes (1)

  • induction time to delivery

    The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.

    Time from induction to delivery, average 12-28 hours

Secondary Outcomes (5)

  • Mode of delivery

    average of 12-28 hours from induction until official time of birth

  • estimated blood loss

    average of 12-28 hours from induction until official time of birth

  • uterine atony

    average of 12-28 hours from induction until official time of birth

  • chorioamnionitis

    average of 12-28 hours from induction until official time of birth

  • neonatal birthweight

    average of 12-28 hours from induction until official time of birth

Study Arms (4)

Control

NO INTERVENTION

No oxytocin while the Foley bulb is in place

Oxytocin

EXPERIMENTAL

Use of oxytocin while the Foley bulb is in place

Drug: Oxytocin

PROMS Foley and oxytocin

EXPERIMENTAL

Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.

Drug: Oxytocin

PROMS no Foley bulb

NO INTERVENTION

Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.

Interventions

OxytocinDRUG

Use of oxytocin while the Foley bulb is in place

Also known as: Pitocin
OxytocinPROMS Foley and oxytocin

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women at \> 24 weeks gestation
  • a non-anomalous, singleton fetus in a vertex presentation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 28651258DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Angela Bianco, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 28, 2014

Study Start

November 1, 2014

Primary Completion

April 18, 2016

Study Completion

April 18, 2016

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

US(2)