Foley Labor Induction Trial at Term and in PROM

Induction of Labor Clinical Trial

Official title:

A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098421
• Other study ID #: GCO 13-1279
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2014
• Last updated: June 9, 2017
• Start date: November 2014
• Est. completion date: April 18, 2016

Study information

• Verified date: June 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: April 18, 2016
• Est. primary completion date: April 18, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• Oxytocin
Use of oxytocin while the Foley bulb is in place

Locations

Country	Name	City	State
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mode of delivery	The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery.	average of 12-28 hours from induction until official time of birth
Secondary	estimated blood loss		average of 12-28 hours from induction until official time of birth
Secondary	uterine atony	uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart.	average of 12-28 hours from induction until official time of birth
Secondary	chorioamnionitis	Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor.	average of 12-28 hours from induction until official time of birth
Secondary	neonatal birthweight		average of 12-28 hours from induction until official time of birth