Prehospital Cervical Ripening Before Induction and the Maternal Experience

Not Applicable

Terminated

• Conditions: Cervical Ripening; Labor, Induced
• Interventions: Device: Outpatient transcervical Foley balloon

• Registration Number: NCT01641601
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-12
• Study First Posted: 2012-07-17
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2020-07
• Results First Submitted: 2020-07-27
• Results First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Results First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient transcervical Foley balloon	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Maternal Satisfaction	up to 48 hours after delivery	Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview.

Trial Locations

Locations (1)

UCSF Benioff Children's Hospital; 🇺🇸 San Francisco, California, United States