Chorioamnionitis
Conditions
Keywords
Intrapartum, Glove, Chorioamnionitis
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.
Interventions
OTHERType of glove used for intrapartum vaginal exams
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed