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Completed

NCT Number: NCT02098421

Foley Labor Induction Trial at Term and in PROM

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).

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Key information

Conditions

Induction of Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Elmhurst Hospital Center, Elmhurst, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxytocin

Drug

Use of oxytocin while the Foley bulb is in place

Other names: Pitocin

Primary outcomes

  1. induction time to delivery

    Time frame: Time from induction to delivery, average 12-28 hours

    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.

Secondary outcomes

  1. Mode of delivery

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

    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.

  2. estimated blood loss

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

  3. uterine atony

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

    uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart.

  4. chorioamnionitis

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

    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.

  5. neonatal birthweight

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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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