Prehospital Cervical Ripening Before Induction and the Maternal Experience ("PRIME")

Randomized Controlled Trial of Prehospital Cervical Ripening With an Outpatient Transcervical Foley Balloon and the Duration of Induction and Maternal Satisfaction

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.

Study Overview

• Status: Terminated
• Conditions: Labor, Induced; Cervical Ripening
• Intervention / Treatment: Device: Outpatient transcervical Foley balloon

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Benioff Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
EXPERIMENTAL: 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.	Device: Outpatient transcervical Foley balloon; A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Inpatient Time Required to Achieve Delivery	Time from admission to the hospital until delivery	From admission to delivery, expected average of 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Satisfaction	Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview.	up to 48 hours after delivery

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Kirsten Salmeen, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2012
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (ESTIMATE): July 17, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Induction of labor; Outpatient cervical ripening
• Other Study ID Numbers: 12-08620