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Completed

NCT Number: NCT02150954

Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.

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Key information

Conditions

Induction of Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a singleton pregnancy
  • Term pregnancy (> 37 weeks gestation)
  • Age ≥ 18 years
  • Bishop score < 5
  • Contractions < 6/hr
  • Reassuring fetal heart tracing

Exclusion criteria

  • Rupture of membranes
  • Antepartum bleeding
  • Fetal death
  • Placenta previa or low lying placenta
  • Active genital herpes infection
  • Previous use of an induction or preinduction agent during the current pregnancy
  • EFW >4500 grams
  • Non reassuring fetal testing
  • Inability to pass foley through cervix
  • Prior cesarean section

Treatment and study plan

Pitocin

Drug

Other names: oxytocin

Primary outcomes

  1. Time to the Second Stage of Labor

    Time frame: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)

    The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.

  2. Time to Delivery

    Time frame: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)

    Time from foley balloon placement until neonate delivery

Secondary outcomes

  1. Rate of Cesarean Delivery

    Time frame: during admission for delivery, up to approximately 4 days

    Number of participants having a cesarean delivery

  2. Time to Active Labor

    Time frame: during admission for delivery, up to approximately 4 days

    Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.

  3. Time to Foley Expulsion or Removal

    Time frame: foley bulb placement until removal, up to 10 hours

    Time from foley balloon placement until the expulsion or removal of the foley balloon.

  4. Incidence of Uterine Hyperstimulation

    Time frame: during admission for delivery, up to approximately 4 days

    Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.

  5. Neonatal Outcome: Birthweight

    Time frame: at time of birth (0 to 1 hour)

  6. Neonatal Outcome: Placental Abruption

    Time frame: during admission for delivery, up to approximately 4 days

    number of participants with placental abruption

  7. Neonatal Outcome: Late Fetal Heart Rate Decelerations

    Time frame: during admission for delivery, up to approximately 4 days

    Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Randomized Comparison of Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 30, 2014
Registry last updated
Oct 26, 2023

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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