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

NCT ID: NCT03064672

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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GBS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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induction by transcervical Balloon Catheters insertion

Group Type EXPERIMENTAL

transcervical Balloon Catheters

Intervention Type DEVICE

induction of labor by transcervical Balloon Catheters insertion

induction without transcervical Balloon Catheters

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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transcervical Balloon Catheters

induction of labor by transcervical Balloon Catheters insertion

Intervention Type DEVICE

Eligibility Criteria

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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.
* 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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doron Kabiri, MD

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Central Contacts

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Myriam Safrai, MD

Role: CONTACT

972-506998982

Hadas Lemberg,, PhD

Role: CONTACT

972-508946898

References

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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.

Reference Type BACKGROUND
PMID: 26719985 (View on PubMed)

Other Identifiers

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BALLOONGBS- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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