Intrapartum Study of Sterile and Clean Gloves

May 15, 2018 updated by: Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

507

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.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

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

Yes

Genders Eligible for Study

Female

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nonsterile
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
Other: Type of glove used for intrapartum vaginal exams
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
Other: Sterile
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
Other: Type of glove used for intrapartum vaginal exams
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical chorioamnionitis
Time Frame: participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs
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
participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

Investigators

  • Study Chair: Donna Johnson, Medical University of South Carolina, Obstetrics-Gynecology
  • Principal Investigator: Laura Houston, MD, Medical University of South Carolina

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 (Actual)

May 1, 2011

Primary Completion (Actual)

November 2, 2014

Study Completion (Actual)

November 2, 2014

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

May 8, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR 20638

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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