Clinical Evaluation of Cervical Ripening in the Outpatient Setting

Study Overview
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Brief Summary
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A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

Detailed Description
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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.

Official Title
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Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial

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

Intervention / Treatment
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* Other: Cervical ripening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone<br>Mifepristone 200mg 24hours before the induction day | Other: Cervical ripening<br>* Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.<br>|
| Active Comparator: Balloon catheter<br>Balloon catheter with 40ml placed 24hours before the induction day | Other: Cervical ripening<br>* Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Bishop score ≥6 | Proportion of patients (%) with Bishop score ≥6 24 hours after intervention | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of gain in Bishop score | Mean of gain in Bishop score from intervention to hospital admission | 24 hours | 
| Number of Participants in active phase of labour (≥4 cm dilatation + ≥ 80% effacement and regular contractions) without need of further medication | Proportion of patients (%) in active phase of labour (≥4 cm dilatation + ≥ 80% effacement and regular contractions) without need of further medication | 1-2 days | 
| Time frame between intervention and active phase of labour | Time frame between intervention and active phase of labour (min) | 1-2 days | 
| Time of Vaginal Delivery | Delivery time frame in mins from intervention | 2-4days | 
| Number of Participants with vaginal delivery within 24hrs | Rate of vaginal deliveries within 24 hours since admission to hospital (%) | 1-2days | 
| Vaginal delivery within 48hrs | Rate of vaginal deliveries within 48 hours since admission to hospital (%) | 1-2days | 
| Pharmacological agents for labor induction (Prostaglandins, Oxytocin) | Rate of women that required pharmacological cervical ripening agents (%) requirement (%) | 1-2days | 
| Operative deliveries | Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance. | 1-4days | 
| Cesarean deliveries | Proportion of patients that delivered by cesarean (%). | 1-4days | 
| Analgesia requirement | Rate of women who require any analgesia during cervical ripening process (%) | 24 hours | 
| Vaginal bleeding | Rate of women who had vaginal bleeding during cervical ripening process (%) | 24 hours | 
| Reduced fetal movements | Rate of women who had reduced fetal movements during cervical ripening process (%) | 24 hours | 
| Non reassuring fetal status | Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%) | 24 hours | 
| Patient Satisfaction: questionnaire | Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire | 1-4days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical ripening, mifepristone, balloon catheter