Status:
COMPLETED
Clinical Evaluation of Cervical Ripening in the Outpatient Setting
Lead Sponsor:
Centro Hospitalar Lisboa Norte
Conditions:
Labor; Forced or Induced, Affecting Fetus or Newborn
Labor Onset and Length Abnormalities
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- Previous cesarean section or myomectomy
- Hypertension
- Diabetes
- Thyroid disease
- Maternal conditions with high risk of placental insufficiency
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04271722
Start Date
January 15 2020
End Date
December 30 2022
Last Update
May 31 2024
Active Locations (1)
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1
Centro Hospitalar Lisboa Norte
Lisbon, Portugal