Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

NCT ID: NCT03111316

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-09
• Study Completion Date: 2020-07-24

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.

Detailed Description

Those who provide informed consent will be allocated by an online randomization system either to placement of a transcervical Foley catheter and an intravaginal dinoprostone controlled release insert or a Foley catheter alone. Randomization will be stratified by parity (nulliparous or parous).

In both study groups, 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. Also in both groups, the Foley catheter will be removed if any of the following occurs: 1) expulsion, 2) fetal heart rate tracing mandating evaluation for membrane rupture and placement of internal monitors, 3) spontaneous membrane rupture, or 4) if 12 hours has elapsed since placement. The dinoprostone insert will be removed if: 1) the fetal heart rate tracing mandates evaluation for membrane rupture and placement of internal monitors, 2) tachysystole develops (more than 5 contractions per 10 minutes averaged over 30 minutes, 3) spontaneous membrane rupture, or 4) 12 hours has elapsed since placement. Though these are the criteria for insert removal, in keeping with the pragmatic design of this trial, the decision regarding removal will be left to the discretion of the attending physician.

Women will remain recumbent for 30 minutes after agent placement and, except for trips to the restroom, will undergo continuous monitoring of uterine contractions and fetal heart rate. Oxytocin, according to standard intravenous protocol, will be allowed only after removal of cervical ripening agent(s). After specified cervical ripening, labor management will be at the discretion of the attending obstetrician, in keeping with the pragmatic nature of the study design.

Antibiotics will be administered if indicated for prophylaxis against early-onset neonatal infection with group B streptococci or for treatment of chorioamnionitis. Cesarean delivery will be performed, per the discretion of the attending obstetrician, for standard maternal or fetal indications.

Medical records will be reviewed no less than 30 days after delivery. Demographic, intrapartum, and outcome data will be entered into a computerized database.

Conditions

Cervical Ripening; Induction of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Foley Catheter & Dinoprostone Insert

transcervical Foley catheter and an intravaginal dinoprostone controlled release insert

Group Type: OTHER

Cervidil 10 MG Vaginal Insert

Intervention Type: 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.

Foley Catheter

Intervention Type: 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 Alone

a Foley catheter alone

Group Type: OTHER

Foley Catheter

Intervention Type: 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.

Interventions

Cervidil 10 MG Vaginal Insert

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.

Intervention Type: DRUG

Foley Catheter

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.

Intervention Type: DEVICE

Other Intervention Names

Dinoprostone

Eligibility Criteria

Inclusion Criteria

1. Cervix ≤2 cm dilated; if 2 cm, <80% effaced

2. Gestational age 37 weeks or more

3. Singleton gestation

4. Cephalic presentation

5. Live fetus

Exclusion Criteria

1. Contractions more frequent than every 5 minutes

2. Premature rupture of membranes

3. Prior uterine incision

4. Temperature 38C or higher

5. Fetal anomalies

6. Placenta previa

7. Suspected abruption or undiagnosed bleeding more than spotting

8. Fetal heart rate tracing prior to enrollment with no more than minimal variability, late decelerations, or more than two variable decelerations

9. HIV infection

10. Allergy to either latex or dinoprostone

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodney K Edwards, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Oklahoma Health Sciences Center

Locations

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 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)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Ferring

Identifier Type: -

Identifier Source: org_study_id