N/A
N=129
Evaluation of CRB in PROM Patients
Premature Rupture of Fetal Membranes
Bottom Line
View on ClinicalTrials.gov: NCT01736852 ↗Enrolled (actual)
129
Serious AEs
7.3%
Results posted
Oct 2020
Primary outcome: Primary: Time of Labor — 850.4; 1016.6 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CRB (Device); Pitocin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cook Group Incorporated
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time of Labor |
850.4; 1016.6 | — |
| PRIMARY Incidence of Infection |
7; 6 | 0.06 |
Summary
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
Eligibility Criteria
Inclusion Criteria
- PROM not in labor
Exclusion Criteria
- Contraindication to vaginal delivery
- Contraindication to labor induction
- Abnormal fetal heart-rate patterns
- Maternal heart disease
- Severe maternal hypertension
- Pelvic structural abnormality
Data sourced from ClinicalTrials.gov (NCT01736852). 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.