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Clinical Trial Summary

The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).


Clinical Trial Description

Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery.

Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.

The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03472937
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Completed
Phase N/A
Start date May 4, 2018
Completion date December 13, 2019

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