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Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial
A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.
Artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. While the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. Cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. More recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day. The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
Yes
Centro Hospitalar Lisboa Norte
Lisbon, Portugal
Start Date
January 15, 2020
Primary Completion Date
December 30, 2022
Completion Date
December 30, 2022
Last Updated
May 31, 2024
101
ACTUAL participants
Cervical ripening
OTHER
Lead Sponsor
Centro Hospitalar Lisboa Norte
NCT04000438
NCT04933708
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