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

Phase 4

Completed

• Conditions: Induction of Labor
• Interventions: Drug: pitocin

• Registration Number: NCT02150954
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-30
• Status Verified: 2014-06
• Results First Submitted: 2014-06-24
• Results First Submitted QC: 2014-06-24
• Results First Posted: 2014-07-23
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
foley bulb induction with low dose pitocin	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.
foley bulb with standard incremental pitocin infusion protocol	pitocin	Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.

Primary Outcome Measures

Name	Time	Method
Time to the Second Stage of Labor	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	foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)	Time from foley balloon placement until neonate delivery

Secondary Outcome Measures

Name	Time	Method
Rate of Cesarean Delivery	during admission for delivery, up to approximately 4 days	Number of participants having a cesarean delivery
Time to Active Labor	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	foley bulb placement until removal, up to 10 hours	Time from foley balloon placement until the expulsion or removal of the foley balloon.
Neonatal Outcome: Placental Abruption	during admission for delivery, up to approximately 4 days	number of participants with placental abruption
Incidence of Uterine Hyperstimulation	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	at time of birth (0 to 1 hour)
Neonatal Outcome: Late Fetal Heart Rate Decelerations	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.