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Intrapartum Study of Sterile and Clean Gloves

Primary Purpose

Chorioamnionitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Type of glove used for intrapartum vaginal exams

About this trial

This is an interventional health services research trial for Chorioamnionitis focused on measuring Intrapartum, Glove, Chorioamnionitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Nonsterile

Sterile

Arm Description

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

Outcomes

Primary Outcome Measures

Clinical chorioamnionitis

Clinical chorioamnionitis with at least two of the four criteria met-maternal fever of 38 degrees Celsius or greater, maternal tachycardia (pulse >100), fetal tachycardia (fetal heart rate >160), and/or fundal tenderness

Secondary Outcome Measures

Full Information

NCT ID

NCT01852188

First Posted

April 18, 2012

Last Updated

May 15, 2018

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01852188

Brief Title

Intrapartum Study of Sterile and Clean Gloves

Official Title

A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

May 2011 (Actual)

Primary Completion Date

November 2, 2014 (Actual)

Study Completion Date

November 2, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of South Carolina

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chorioamnionitis

Keywords

Intrapartum, Glove, Chorioamnionitis

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

507 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nonsterile

Arm Type

Other

Arm Description

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

Arm Title

Sterile

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Type of glove used for intrapartum vaginal exams

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical chorioamnionitis

Description

Time Frame

participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Houston, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Donna Johnson

Organizational Affiliation

Medical University of South Carolina, Obstetrics-Gynecology

Official's Role

Study Chair

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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Intrapartum Study of Sterile and Clean Gloves

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