Outpatient Versus Inpatient Cervix Priming With Foley Catheter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- variation of bishop score (difference between bishop score before and after application of foley catheter)
Study Overview
Brief Summary
The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score < 6, gestational age > 41 weeks or medical indication for induction of labor.
Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.
The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •women with a single fetus in cephalic presentation
- •Bishop score < 6
- •Gestational age > 41 weeks or medical indication for induction of labor submitted to cervix priming with Foley catheter
Exclusion Criteria
- •women with a fetus in noncephalic presentation
- •an indication for elective cesarean delivery
- •spontaneous labor
- •hydramnios (amniotic fluid index ≥ 25)
- •nonreassuring cardiotocogram
- •multiple pregnancy
- •rupture of membranes
- •active vaginal bleeding
- •indication for prophylaxis of Streptococcus group B infection
- •HIV infection
- •cervical injury
- •previous cesarean section with recurrent indication
Outcomes
Primary Outcomes
variation of bishop score (difference between bishop score before and after application of foley catheter)
Time Frame: up to 24 months
Secondary Outcomes
- mode of delivery(up to 24 months)
- maternal pain evaluated by visual analog scale for pain(up to 24 months)
- induction-to-delivery time(up to 24 months)
Investigators
Catarina Policiano
Dr. Catarina Policiano
Hospital de Santa Maria, Portugal