Prehospital Cervical Ripening Before Induction and the Maternal Experience

Cervical Ripening Clinical Trial

— "PRIME"  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01641601
• Other study ID #: 12-08620
• Status: Terminated
• Phase: N/A
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening
• Labor, Induced

Intervention

Device:
• Outpatient transcervical Foley balloon
A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal Satisfaction	Maternal satisfaction with the period leading up to admission and the hospital stay, measured by interview.	up to 48 hours after delivery