Transcervical Balloon Catheters in GBS Carriers, Is It Safe? A Randomized Controlled Trial
1 other identifier
interventional
500
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 22, 2020
August 1, 2020
4 months
February 22, 2017
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
composite adverse maternal outcomes
2-3 days
Study Arms (2)
induction by transcervical Balloon Catheters insertion
EXPERIMENTALinduction without transcervical Balloon Catheters
NO INTERVENTIONInterventions
induction of labor by transcervical Balloon Catheters insertion
Eligibility Criteria
You may qualify if:
- During the study period and in the absence of contraindications, women anticipating induction of labor with unripe cervix will be screened for eligibility.
- Gestational age between 37+0/7 and 41+6/7 weeks'
- Intact membranes
- Reactive non-stress test and Bishop's score \< 6.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 26719985BACKGROUND
Study Officials
- STUDY DIRECTOR
Doron Kabiri, MD
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2017
First Posted
February 27, 2017
Study Start
December 1, 2020
Primary Completion
April 1, 2021
Study Completion
December 1, 2021
Last Updated
October 22, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share
The data of the mother and the baby will be checked and recorded. At the end of the study, all the data are gonna be analyzed. In case of a severe bad outcome, the data will be checked during the study to make sure that the study is not the cause.