Clinical Evaluation of Cervical Ripening in the Outpatient Setting

Centro Hospitalar Lisboa Norte

Status: Completed

Conditions: Labor Onset and Length Abnormalities; Labor; Forced or Induced, Affecting Fetus or Newborn

Treatments: Other: Cervical ripening

Study type: Interventional

Funder types: Other

Identifiers

NCT04271722

2020OBST1

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Mifepristone

Experimental group

Description:

Mifepristone 200mg 24hours before the induction day

Treatment:

Other: Cervical ripening

Balloon catheter

Active Comparator group

Description:

Balloon catheter with 40ml placed 24hours before the induction day

Treatment:

Other: Cervical ripening