Clinical Evaluation of Cervical Ripening in the Outpatient Setting
- Conditions
- Labor; Forced or Induced, Affecting Fetus or NewbornLabor Onset and Length Abnormalities
- Interventions
- Other: Cervical ripening
- Registration Number
- NCT04271722
- Lead Sponsor
- Centro Hospitalar Lisboa Norte
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 101
- 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
- Previous cesarean section or myomectomy
- Hypertension
- Diabetes
- Thyroid disease
- Maternal conditions with high risk of placental insufficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Balloon catheter Cervical ripening Balloon catheter with 40ml placed 24hours before the induction day Mifepristone Cervical ripening Mifepristone 200mg 24hours before the induction day
- Primary Outcome Measures
Name Time Method Number of Participants with Bishop score ≥6 or spontaneous labour 24 hours Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention
- Secondary Outcome Measures
Name Time Method Mean of gain in Bishop score 24 hours Mean of gain in Bishop score from intervention to hospital admission
Operative deliveries 1-4days Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Cesarean deliveries 1-4days Proportion of patients that delivered by cesarean (%).
Reduced fetal movements 24 hours Rate of women who had reduced fetal movements during cervical ripening process (%)
Non reassuring fetal status 24 hours Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)
Patient Satisfaction: questionnaire 1-4days Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire
Time of Vaginal Delivery 2-4days Delivery time frame in mins from intervention
Analgesia requirement 24 hours Rate of women who require any analgesia during cervical ripening process (%)
Time frame between intervention and active phase of labour 1-2 days Time frame between intervention and active phase of labour (min)
Number of Participants with vaginal delivery within 24hrs 1-2days Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Vaginal delivery within 48hrs 1-2days Rate of vaginal deliveries within 48 hours since admission to hospital (%)
Pharmacological agents for labor induction (Prostaglandins, Oxytocin) 1-2days Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Vaginal bleeding 24 hours Rate of women who had vaginal bleeding during cervical ripening process (%)
Trial Locations
- Locations (1)
Centro Hospitalar Lisboa Norte
🇵🇹Lisboa, Portugal