Phase 4
N=117
Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor
Induction of Labor
Bottom Line
View on ClinicalTrials.gov: NCT02150954 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Time to the Second Stage of Labor — 18.2; 14.6 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pitocin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the Second Stage of Labor |
18.2; 14.6 | — |
| PRIMARY Time to Delivery |
23.7; 19.1 | — |
| SECONDARY Rate of Cesarean Delivery |
22; 20 | — |
| SECONDARY Time to Active Labor |
9.3; 12.2 | — |
| SECONDARY Time to Foley Expulsion or Removal |
4.5; 5.6 | — |
| SECONDARY Incidence of Uterine Hyperstimulation |
7; 11 | — |
| SECONDARY Neonatal Outcome: Birthweight |
3065; 3180 | — |
| SECONDARY Neonatal Outcome: Placental Abruption |
0; 0 | — |
| SECONDARY Neonatal Outcome: Late Fetal Heart Rate Decelerations |
14; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with a singleton pregnancy
- Term pregnancy (> 37 weeks gestation)
- Age ≥ 18 years
- Bishop score 4500 grams
- Non reassuring fetal testing
- Inability to pass foley through cervix
- Prior cesarean section
Data sourced from ClinicalTrials.gov (NCT02150954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.