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

A Randomized Comparison of 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.

Study Overview

• Status: Completed
• Conditions: Induction of Labor
• Intervention / Treatment: Drug: pitocin

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: pitocin; Other Names: oxytocin
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.	Drug: pitocin; Other Names: oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the Second Stage of Labor	The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.	foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
Time to Delivery	Time from foley balloon placement until neonate delivery	foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Cesarean Delivery	Number of participants having a cesarean delivery	during admission for delivery, up to approximately 4 days
Time to Active Labor	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.	during admission for delivery, up to approximately 4 days
Time to Foley Expulsion or Removal	Time from foley balloon placement until the expulsion or removal of the foley balloon.	foley bulb placement until removal, up to 10 hours
Incidence of Uterine Hyperstimulation	Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.	during admission for delivery, up to approximately 4 days
Neonatal Outcome: Birthweight		at time of birth (0 to 1 hour)
Neonatal Outcome: Placental Abruption	number of participants with placental abruption	during admission for delivery, up to approximately 4 days
Neonatal Outcome: Late Fetal Heart Rate Decelerations	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.	during admission for delivery, up to approximately 4 days

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Chad Grotegut, MD, Duke University; Principal Investigator: Brennan Fitzpatrick, MD, Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimated): May 30, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: induction of labor; pitocin; foley bulb
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: Pro00001312