Intrapartum Study of Sterile and Clean Gloves

Not Applicable

Completed

• Conditions: Chorioamnionitis
• Interventions: Other: Type of glove used for intrapartum vaginal exams

• Registration Number: NCT01852188
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-13
• Primary Completion: 2014-11-02
• Study Completion: 2014-11-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 507

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonsterile	Type of glove used for intrapartum vaginal exams	Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
Sterile	Type of glove used for intrapartum vaginal exams	Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Primary Outcome Measures

Name	Time	Method
Clinical chorioamnionitis	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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States