Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial

Hadassah Medical Center

Status: Unknown

Conditions: GBS

Treatments: Device: transcervical Balloon Catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT03064672

BALLOONGBS- HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

induction by transcervical Balloon Catheters insertion

Experimental group

Treatment:

Device: transcervical Balloon Catheters

induction without transcervical Balloon Catheters

No Intervention group