Clinical Evaluation of Cervical Ripening in the Outpatient Setting

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Centro Hospitalar Lisboa Norte
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Updated on 16 February 2024
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Summary

A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

Description

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.

Details
Condition Labor; Forced or Induced, Affecting Fetus or Newborn, Labor Onset and Length Abnormalities
Age 18years - 45years
Treatment Cervical ripening
Clinical Study IdentifierNCT04271722
SponsorCentro Hospitalar Lisboa Norte
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Pregnant woman scheduled for induction of labor
Age between 18 and 45 years
Understanding and capable to sign informed consent
Singleton pregnancy
Gestational age 37 0/7 weeks
Live fetus in cephalic presentation
Intact membranes
Bishop score < 6
Estimated fetal weight < 4500g
Without contraindication to vaginal delivery
No major fetal anomaly

Exclusion Criteria

Previous cesarean section or myomectomy
Hypertension
Diabetes
Thyroid disease
Maternal conditions with high risk of placental insufficiency
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