Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

Not Applicable

Completed

Conditions: Cervical Ripening
Induction of Labor

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

Registration Number: NCT03111316

Lead Sponsor: University of Oklahoma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley Catheter & Dinoprostone Insert	Foley Catheter	transcervical Foley catheter and an intravaginal dinoprostone controlled release insert
Foley Catheter Alone	Foley Catheter	a Foley catheter alone
Foley Catheter & Dinoprostone Insert	Cervidil 10 MG Vaginal Insert	transcervical Foley catheter and an intravaginal dinoprostone controlled release insert

Primary Outcome Measures

Name	Time	Method
The Median Times From Placement of Foley Catheter to Vaginal Delivery	48 hours	median time estimation for use of dinoprostone and foley catheter and foley catheter alone

Secondary Outcome Measures

Name	Time	Method
To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours	24 hours	To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours.