Phase 4
Completed N=323
Foley With Oxytocin Versus Foley no Oxytocin for Induction of Labor
Labor; Forced or Induced, Affecting Fetus or Newborn
Source: ClinicalTrials.gov NCT02273115 ↗
Enrolled (actual)
323
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Delivery Rate — 40; 58; 48; 62 Participants
◆ Published Evidence
Highly cited
139citations · ~46 / year
Mechanical methods for induction of labour.
Summary
The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.
Linked Publications (3)
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Mechanical methods for induction of labour.
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Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial.
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Intracervical Foley catheter with and without oxytocin for labor induction with Bishop score ≤3: a secondary analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delivery Rate |
40; 58; 48; 62 | — |
| SECONDARY Number of Participants With Time to Delivery Achieved Within 12 Hours |
2; 7; 13; 23 | — |
| SECONDARY Total Time to Delivery |
26.1; 20.9; 18.6; 14.9 | — |
| SECONDARY Time to Foley Expulsion |
11.8; 7.2; 7.9; 5.8 | — |
| SECONDARY Number of Vaginal Deliveries |
59; 49; 54; 59 | — |
| SECONDARY Regional Analgesia |
2; 13; 1; 11 | — |
| SECONDARY Obstetric Complications |
8; 10; 1; 3; 17; 11 | — |
| SECONDARY Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 |
27; 23; 12; 11; 5; 0 | — |
| SECONDARY Neonatal Outcome: Neonatal Weight |
3301; 3278; 3177; 3164 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than 18 years
- Pregnant, singleton gestation, vertex presentation
- Admitted for induction of labor between gestational ages 24 - 42 weeks
- Bishop score 50% of contractions
- 2 or more previous cesarean section, myomectomy, or classical cesarean
- Need to use ripening agents prior to Foley placement
- Spontaneous labor
- Active genital herpes
- Inability to consent
- Any contraindication to a vaginal delivery
Data sourced from ClinicalTrials.gov (NCT02273115) and the linked publication. 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. Informational only — not medical advice.