GBS Clinical Trial
Official title:
Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Kabiri D, Hants Y, Yarkoni TR, Shaulof E, Friedman SE, Paltiel O, Nir-Paz R, Aljamal WE, Ezra Y. Antepartum Membrane Stripping in GBS Carriers, Is It Safe? (The STRIP-G Study). PLoS One. 2015 Dec 31;10(12):e0145905. doi: 10.1371/journal.pone.0145905. eCollection 2015. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | adverse neonatal outcomes | the incidence of composite adverse neonatal outcomes based on the NICE criteria for early detection of neonatal sepsis | 2-3 days | |
Secondary | composite adverse maternal outcomes | chorioamnionitis, suspected chorioamnionitis or endometritis, urinary tract infection or sepsis in the peripartum period, prolonged hospital stay, and allergic reaction to antibiotics | 2-3 days |
Status | Clinical Trial | Phase | |
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