GBS
Conditions
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.
Interventions
DEVICEtranscervical Balloon Catheters
induction of labor by transcervical Balloon Catheters insertion
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMyriam Safrai, MD
Backup ContactHadas Lemberg,, PhD
Outcome results
None listed