Phase 2
N=240
Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
Induction of Labor Affected Fetus / Newborn
Bottom Line
View on ClinicalTrials.gov: NCT03348683 ↗Enrolled (actual)
240
Serious AEs
0.4%
Results posted
Dec 2019
Primary outcome: Primary: Time From Beginning of Induction to Delivery — 13.8; 14.3 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Propranolol (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Beginning of Induction to Delivery |
13.8; 14.3 | — |
| SECONDARY Number of Participants With Various Mode of Delivery |
64; 61; 3; 10; 8; 8 | — |
| SECONDARY Duration of Latent |
11.0; 11.2 | — |
| SECONDARY Number of Participants With Maternal Morbidity Composite Score = 1 |
35; 49 | — |
| SECONDARY Number of Participants With Postpartum Hemorrhage |
15; 26 | — |
| SECONDARY Number of Fetus With Heart Rate Decelerations |
15; 13 | — |
| SECONDARY Number of Fetus With Fetal Bradycardia |
1; 0 | — |
| SECONDARY Number of Neonates With Neonatal Outcome Composite Score = 1 |
21; 28 | — |
| SECONDARY Number of Neonates With Hypoglycemia |
11; 8 | — |
Summary
A randomized, prospective trial will be offered to women admitted to the labor floors at Mount Sinai Medical Center for labor induction.
Eligibility Criteria
Inclusion Criteria
- Nulliparous women undergoing induction of labor
- >37 weeks' gestational age
- Non-anomalous, singleton cephalic presenting fetus.
Exclusion Criteria
- Multiple gestations, known fetal anomalies
- Maternal cardiac or hypertensive disease
- Chronic beta blocker use
- Bronchial asthma
- Maternal or fetal indication for immediate delivery.
Data sourced from ClinicalTrials.gov (NCT03348683). 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.