Clinical Evaluation of Cervical Ripening in the Outpatient Setting

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.

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