Chorioamnionitis Clinical Trial
Official title:
A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial
NCT number | NCT01852188 |
Other study ID # | HR 20638 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | November 2, 2014 |
Verified date | May 2018 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 507 |
Est. completion date | November 2, 2014 |
Est. primary completion date | November 2, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical chorioamnionitis | 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 |
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