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

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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

  • 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

Trial design

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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