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

GBS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03064672
• Other study ID #: BALLOONGBS- HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Hadassah Medical Organization
• Contact: Myriam Safrai, MD
• Phone: 972-506998982
• Email: myriamsafrai[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• GBS

Intervention

Device:
• transcervical Balloon Catheters
induction of labor by transcervical Balloon Catheters insertion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

References & Publications (1)

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

Outcome

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