Fetal Membranes, Premature Rupture, Labor, Induced/IS
Conditions
Keywords
Fetal Membranes, Premature Rupture, Labor, Induced, Foley Catheter
Brief summary
In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.
Detailed description
To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at \> 34 weeks.
Interventions
Foley catheter placed through cervix for cervical ripening
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction 2. Cervix ≤ 2 centimeters (cm) 3. Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery 4. Singleton gestation 5. Cephalic 6. Vertex well applied to cervix
Exclusion criteria
1. Regular uterine contractions (contractions more frequent than every 5 minutes) 2. Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor 3. Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge) 4. Lethal fetal anomalies 5. Intrauterine fetal demise (IUFD) 6. Previa 7. Suspected abruption/significant hemorrhage 8. Non-reassuring fetal heart rate (FHR) pattern 9. Non vertex fetal presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hours From Placement of Foley or Initiation of Oxytocin to Delivery | Time from induction to delivery | The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Delivery (Vaginal or Cesarean)by 24 Hours | from start of induction to 24 hours post start of induction | The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours. |
| Cesarean Rate | at delivery | The percent of subjects enrolled who had a cesarean at any time for any reason for delivery. |
| Induction to Vaginal Delivery Interval | time from induction to vaginal delivery, up to 24 hours | Mean hours from time of induction to vaginal delivery interval. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcervical Foley Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin | 87 |
| No Foley No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin | 82 |
| Total | 169 |
Baseline characteristics
| Characteristic | No Foley | Transcervical Foley | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants | 87 Participants | 169 Participants |
| Age, Continuous | 25 years STANDARD_DEVIATION 6 | 25 years STANDARD_DEVIATION 5 | 25 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 82 participants | 87 participants | 169 participants |
| Sex: Female, Male Female | 82 Participants | 87 Participants | 169 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 | — / — | — / — |
| other Total, other adverse events | 0 / 87 | 0 / 82 |
| serious Total, serious adverse events | 0 / 87 | 0 / 82 |
Outcome results
Primary
Hours From Placement of Foley or Initiation of Oxytocin to Delivery
The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)
Time frame: Time from induction to delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Transcervical Foley | Hours From Placement of Foley or Initiation of Oxytocin to Delivery | 10.8 hours |
| No Foley | Hours From Placement of Foley or Initiation of Oxytocin to Delivery | 12.1 hours |
Secondary
Cesarean Rate
The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.
Time frame: at delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transcervical Foley | Cesarean Rate | 14 percentage of subjects |
| No Foley | Cesarean Rate | 23 percentage of subjects |
Secondary
Induction to Vaginal Delivery Interval
Mean hours from time of induction to vaginal delivery interval.
Time frame: time from induction to vaginal delivery, up to 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Transcervical Foley | Induction to Vaginal Delivery Interval | 10.7 hours |
| No Foley | Induction to Vaginal Delivery Interval | 11.6 hours |
Secondary
Rate of Delivery (Vaginal or Cesarean)by 24 Hours
The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.
Time frame: from start of induction to 24 hours post start of induction
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transcervical Foley | Rate of Delivery (Vaginal or Cesarean)by 24 Hours | 96 percentage of deliveries |
| No Foley | Rate of Delivery (Vaginal or Cesarean)by 24 Hours | 97 percentage of deliveries |