Intrapartum Study of Sterile and Clean Gloves
- Conditions
- Chorioamnionitis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 507
- 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
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina🇺🇸Charleston, South Carolina, United States