Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial
Not Applicable
- Conditions
- GBS
- Interventions
- Device: transcervical Balloon Catheters
- Registration Number
- NCT03064672
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
This prospective cohort study aims to determine whether maternal and neonatal outcomes are affected by GBS carrier status in women undergoing transcervical balloon catheter insertion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
- During the study period and in the absence of contraindications, women anticipating induction of labor with unripe cervix will be screened for eligibility.
- Inclusion criteria are singleton gestation with confirmed cephalic presentation
- Gestational age between 37+0/7 and 41+6/7 weeks'
- Intact membranes
- Reactive non-stress test and Bishop's score < 6.
Exclusion Criteria
- Women less than 18 years, with multiple gestation pregnancies, pregnancies with major fetal anomalies, vaginal infection, intrauterine fetal death and those who were not candidates for vaginal delivery (placenta previa, non-cephalic presentation, planned cesarean delivery).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description induction by transcervical Balloon Catheters insertion transcervical Balloon Catheters -
- Primary Outcome Measures
Name Time Method adverse neonatal outcomes 2-3 days the incidence of composite adverse neonatal outcomes based on the NICE criteria for early detection of neonatal sepsis
- Secondary Outcome Measures
Name Time Method composite adverse maternal outcomes 2-3 days chorioamnionitis, suspected chorioamnionitis or endometritis, urinary tract infection or sepsis in the peripartum period, prolonged hospital stay, and allergic reaction to antibiotics