Trials / Completed
CompletedNCT01736852
Evaluation of CRB in PROM Patients
Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Cook Group Incorporated · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CRB | Labor induction using the CRB |
| DRUG | Pitocin | Labor induction using Pitocin |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
- First posted
- 2012-11-29
- Last updated
- 2020-10-20
- Results posted
- 2020-10-20
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01736852. Inclusion in this directory is not an endorsement.