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

Overview

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.

Full Title of Study: “A Randomized Comparison of Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2009

Interventions

  • Drug: pitocin

Arms, Groups and Cohorts

  • Active Comparator: foley bulb induction with low dose pitocin
    • Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
  • Active Comparator: foley bulb with standard incremental pitocin infusion protocol
    • Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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 Measures

  • Rate of Cesarean Delivery
    • Time Frame: during admission for delivery, up to approximately 4 days
    • Number of participants having a cesarean delivery
  • 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.
  • 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.
  • 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.
  • Neonatal Outcome: Birthweight
    • Time Frame: at time of birth (0 to 1 hour)
  • Neonatal Outcome: Placental Abruption
    • Time Frame: during admission for delivery, up to approximately 4 days
    • number of participants with placental abruption
  • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Patients with a singleton pregnancy 2. Term pregnancy (> 37 weeks gestation) 3. Age ≥ 18 years 4. Bishop score < 5 5. Contractions < 6/hr 6. Reassuring fetal heart tracing Exclusion Criteria:

1. Rupture of membranes 2. Antepartum bleeding 3. Fetal death 4. Placenta previa or low lying placenta 5. Active genital herpes infection 6. Previous use of an induction or preinduction agent during the current pregnancy 7. EFW >4500 grams 8. Non reassuring fetal testing 9. Inability to pass foley through cervix 10. Prior cesarean section

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chad Grotegut, MD, Principal Investigator, Duke University
    • Brennan Fitzpatrick, MD, Principal Investigator, Duke University

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