Cervical Ripening, Labor, Induced
Conditions
Keywords
Induction of labor, Outpatient cervical ripening
Brief summary
This is a randomized study evaluating the impact of pre-hospital cervical ripening with a transcervical Foley balloon before labor induction in full-term pregnancies on the length of inpatient labor induction and maternal satisfaction with the labor induction process. The investigators hypothesize that women who receive pre-hospital cervical ripening will have a shorter duration of inpatient labor induction as compared to women without pre-hospital cervical ripening.
Detailed description
Labor induction is a common procedure among pregnant patients at term. This process involves a period of cervical preparation (ripening) for women who have an unfavorable cervical examination at the time labor induction is scheduled. Cervical ripening may take place with pharmacologic or mechanical strategies, which at this time are traditionally administered on an inpatient basis. This process can 24 or more hours, resulting in a lengthy hospitalization with the associated costs and frustrations for both patients and L&D staff. The proposed study is a randomized, controlled trial to explore the following research question: Among women with full-term pregnancies requiring labor induction, does pre-hospital, outpatient cervical ripening reduce the amount of inpatient time needed to achieve delivery as compared to no pre-hospital cervical ripening? As a secondary objective, we also wish to explore if outpatient cervical ripening is acceptable to patients. This study will involve randomizing eligible and consenting women who have been scheduled for labor induction by their obstetrical providers into a pre-hospital cervical ripening (intervention) group or a no pre-hospital ripening (control) group. A trans-cervical Foley balloon (TCFB) will be used for outpatient pre-hospital cervical ripening in women randomized to the intervention group. No pre-hospital ripening will be performed for women in the control group. Both groups will be admitted for induction as scheduled and will undergo labor induction according to a specified, Bishop-score based induction protocol, which may or may not include a TCFB. We will compare the duration of inpatient stays from admission until delivery between the groups as well as satisfaction with the pre-hospital period and labor and delivery experience. Maternal and neonatal outcomes will also be compared between the two groups.
Interventions
A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Intrauterine pregnancy * Cephalic presentation * Greater than 36 weeks estimated gestational age * Reassuring fetal status * Normal amniotic fluid index * Clinical indication for induction of labor
Exclusion criteria
* Prior cesarean section * Bishop score on cervical examination ≥ 6 * Unreliable transportation * Home \> 30 minutes from the hospital * Non-reassuring fetal status * Abnormal amniotic fluid index * Other indication for immediate hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Inpatient Time Required to Achieve Delivery | From admission to delivery, expected average of 48 hours | Time from admission to the hospital until delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Satisfaction | up to 48 hours after delivery | Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Management Patients in the usual management arm will have no pre-hospital cervical ripening and will undergo labor induction according to standard labor induction protocols on an inpatient basis. | 0 |
| Outpatient Transcervical Foley Balloon Patients in the experimental group will have a 30 cc transcervical Foley balloon placed in the outpatient setting approximately 12-18 hours prior to their labor induction. Once admitted, they will undergo inpatient labor induction as per usual protocols.
Outpatient transcervical Foley balloon: A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction. | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study discontinued. | 3 | 5 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 0 / 3 | 0 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 |
Outcome results
Primary
Duration of Inpatient Time Required to Achieve Delivery
Time from admission to the hospital until delivery
Time frame: From admission to delivery, expected average of 48 hours
Population: Study terminated prior to data collection.
Secondary
Maternal Satisfaction
Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview.
Time frame: up to 48 hours after delivery
Population: Study terminated prior to data collection.