Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening

Completed · Not applicable

Conditions studied: Cervical Ripening, Induction of Labor

In brief

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.

Key facts

Study ID

NCT03111316

Run by

University of Oklahoma

People needed

100

Starts

2017-04-09

Expected to finish

2020-07-24

Last updated by the study team

2021-03-24

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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