Intrapartum Study of Sterile and Clean Gloves

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Chorioamnionitis

Treatments: Other: Type of glove used for intrapartum vaginal exams

Study type: Interventional

Funder types: Other

Identifiers

NCT01852188

HR 20638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 507 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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507 participants in 2 patient groups

Nonsterile

Other group

Description:

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

Treatment:

Other: Type of glove used for intrapartum vaginal exams

Sterile

Other group

Description:

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

Treatment:

Other: Type of glove used for intrapartum vaginal exams