Prehospital Cervical Ripening Before Induction and the Maternal Experience

NCT01641601 | Terminated Results

• 1 other identifier: 12-08620
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor, Induced; Cervical Ripening

Keywords

Induction of labor; Outpatient cervical ripening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maternal Satisfaction

  up to 48 hours after delivery

Study Arms (2)

Usual Management

NO INTERVENTION

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.

Outpatient transcervical Foley balloon

EXPERIMENTAL

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

Interventions

Outpatient transcervical Foley balloon DEVICE

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

Outpatient transcervical Foley balloon

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Intrauterine pregnancy
• Cephalic presentation
• Greater than 36 weeks estimated gestational age
• Reassuring fetal status
• Normal amniotic fluid index
• Clinical indication for induction of labor

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Benioff Children's Hospital

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 36996264 DERIVED

Results Point of Contact

• Title: Kirsten Salmeen
• Organization: UCSF

kesalmeen@gmail.com

628-213-5314

Study Officials

• Kirsten Salmeen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 5, 2020
• Results First Posted: August 5, 2020

Record last verified: 2020-07

Locations

US (1)