Prehospital Cervical Ripening Before Induction and the Maternal Experience

NCT ID: NCT01641601

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Labor, Induced; Cervical Ripening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Outpatient transcervical Foley balloon

Intervention Type: DEVICE

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

Interventions

Outpatient transcervical Foley balloon

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten Salmeen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Benioff Children's Hospital

San Francisco, California, United States

Countries

United States

References

de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type: DERIVED

PMID: 36996264 (View on PubMed)

Other Identifiers

12-08620

Identifier Type: -

Identifier Source: org_study_id