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

October 19, 2020 updated by: Hadassah Medical Organization
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: induction by transcervical Balloon Catheters insertion
Device: transcervical Balloon Catheters
induction of labor by transcervical Balloon Catheters insertion
No Intervention: induction without transcervical Balloon Catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse neonatal outcomes
Time Frame: 2-3 days
the incidence of composite adverse neonatal outcomes based on the NICE criteria for early detection of neonatal sepsis
2-3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite adverse maternal outcomes
Time Frame: 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
2-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Study Director: Doron Kabiri, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • BALLOONGBS- HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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