Premature Rupture of Fetal Membranes
Conditions
Keywords
Premature Rupture of Membrane (Pregnancy), PROM, Cervical Ripening, Induced Labor
Brief 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).
Interventions
DEVICECRB
Labor induction using the CRB
DRUGPitocin
Labor induction using Pitocin
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Labor | Start of labor induction through delivery, an expected average of 6 hours | Time, in minutes, from the start of labor induction through delivery |
| Incidence of Infection | Through hospital discharge, an expected average of 3 days | number of patients with chorioamnionitis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CRB Plus Pitocin CRB: Labor induction using the CRB
Pitocin: Labor induction using Pitocin | 64 |
| Pitocin Pitocin: Labor induction using Pitocin | 61 |
| Total | 125 |
Baseline characteristics
| Characteristic | CRB Plus Pitocin | Pitocin | Total |
|---|---|---|---|
| Age, Continuous | 25.0 years STANDARD_DEVIATION 5.1 | 26.3 years STANDARD_DEVIATION 5.5 | 25.7 years STANDARD_DEVIATION 5.3 |
| Bishop score at time of enrollment | 4.4 units on a scale STANDARD_DEVIATION 1.4 | 4.1 units on a scale STANDARD_DEVIATION 1.4 | 4.2 units on a scale STANDARD_DEVIATION 1.5 |
| Gestational age (weeks/days) 34/0 - 36/6 | 12 Participants | 12 Participants | 24 Participants |
| Gestational age (weeks/days) 37/0 - 42/6 | 52 Participants | 49 Participants | 101 Participants |
| Multiple (2 or more) previous pregnancies | 31 Participants | 28 Participants | 59 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized First Nation | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 29 Participants | 27 Participants | 56 Participants |
| Race/Ethnicity, Customized Hispanic or Latino/White | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Female | 64 Participants | 61 Participants | 125 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 61 |
| other Total, other adverse events | 27 / 63 | 21 / 61 |
| serious Total, serious adverse events | 5 / 63 | 4 / 61 |
Outcome results
Primary
Incidence of Infection
number of patients with chorioamnionitis
Time frame: Through hospital discharge, an expected average of 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CRB Plus Pitocin | Incidence of Infection | 7 Participants |
| Pitocin | Incidence of Infection | 6 Participants |
Comparison: .ample size calculations were performed using an expected rate of 4% for each group,a one-sided exact test, α = 0.025, power = 0.80, non-inferiority margin of 10% resulting in a sample size of 124 patients or 62 patients per treatment arm.p-value: 0.06Fisher Exact
Primary
Time of Labor
Time, in minutes, from the start of labor induction through delivery
Time frame: Start of labor induction through delivery, an expected average of 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CRB Plus Pitocin | Time of Labor | 850.4 Minutes | Standard Deviation 417.6 |
| Pitocin | Time of Labor | 1016.6 Minutes | Standard Deviation 595.7 |