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

Duke University

Status and phase: Completed; Phase 4

Conditions: Induction of Labor

Treatments: Drug: pitocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02150954

Pro00001312

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

foley bulb induction with low dose pitocin

Active Comparator group

Description:

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.

Treatment:

Drug: pitocin

foley bulb with standard incremental pitocin infusion protocol

Active Comparator group

Description:

Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.

Treatment:

Drug: pitocin