Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

NCT03111316 | Completed Results FDA Device

• 1 other identifier: Ferring
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In term women presenting for labor induction, combined use of the controlled release dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median time from induction to vaginal delivery by at least four hours compared to the Foley catheter alone.

Conditions

Cervical Ripening; Induction of Labor

Keywords

Cervical Ripening; Induction of Labor

Outcome Measures

Primary Outcomes (1)

• The Median Times From Placement of Foley Catheter to Vaginal Delivery

  median time estimation for use of dinoprostone and foley catheter and foley catheter alone

  48 hours

Secondary Outcomes (1)

• To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours

  24 hours

Study Arms (2)

Foley Catheter & Dinoprostone Insert

OTHER

transcervical Foley catheter and an intravaginal dinoprostone controlled release insert

Drug: Cervidil 10 MG Vaginal Insert; Device: Foley Catheter

Foley Catheter Alone

OTHER

a Foley catheter alone

Device: Foley Catheter

Interventions

Cervidil 10 MG Vaginal Insert DRUG

Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

Also known as: Dinoprostone

Foley Catheter & Dinoprostone Insert

Foley Catheter DEVICE

The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.

Foley Catheter & Dinoprostone Insert; Foley Catheter Alone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cervix ≤2 cm dilated; if 2 cm, \<80% effaced
• Gestational age 37 weeks or more
• Singleton gestation
• Cephalic presentation
• Live fetus

You may not qualify if:

• Contractions more frequent than every 5 minutes
• Premature rupture of membranes
• Prior uterine incision
• Temperature 38C or higher
• Fetal anomalies
• Placenta previa
• Suspected abruption or undiagnosed bleeding more than spotting
• Fetal heart rate tracing prior to enrollment with no more than minimal variability, late decelerations, or more than two variable decelerations
• HIV infection
• Allergy to either latex or dinoprostone

Sponsors & Collaborators

• University of Oklahoma: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, 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

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Director of Women's Health Research
• Organization: University of Oklahoma Health Sciences Center

christy-zornes@ouhsc.edu

4052718001

Study Officials

• Rodney K Edwards, MD

  The University of Oklahoma Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: April 12, 2017
• Study Start: April 9, 2017
• Primary Completion: January 5, 2018
• Study Completion: July 24, 2020
• Last Updated: March 24, 2021
• Results First Posted: May 3, 2019

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)