Intrapartum Study of Sterile and Clean Gloves

NCT ID: NCT01852188

Last Updated: 2018-05-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-11-02

Brief Summary

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The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis. Chorioamnionitis is an infection of the membranes around the baby.

Detailed Description

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The importance of this study is that intrapartum vaginal exams (while patients are laboring) are performed routinely in modern obstetrical practice, and there is no randomized trial available assessing the relationship between the type of glove used and the rate of chorioamnionitis.

Conditions

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Chorioamnionitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Nonsterile

Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Group Type OTHER

Type of glove used for intrapartum vaginal exams

Intervention Type OTHER

Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Sterile

Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Group Type OTHER

Type of glove used for intrapartum vaginal exams

Intervention Type OTHER

Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Interventions

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Type of glove used for intrapartum vaginal exams

Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Spontaneous or induced labor
* Rupture of membranes \< 12 hours
* Nulliparous or multiparous
* Gestational age greater than or equal to 34 weeks
* Age greater than or equal to 18

Exclusion Criteria

* Contraindications to labor
* Multiple gestations
* Rupture of Membranes greater than 12 hours
* Gestational age less than 34 weeks
* Non-English speaking patients
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Houston, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Donna Johnson

Role: STUDY_CHAIR

Medical University of South Carolina, Obstetrics-Gynecology

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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HR 20638

Identifier Type: -

Identifier Source: org_study_id

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