Intrapartum Study of Sterile and Clean Gloves

Chorioamnionitis Clinical Trial

Official title:

A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852188
• Other study ID #: HR 20638
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: November 2, 2014

Study information

• Verified date: May 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Chorioamnionitis

Intervention

Other:
• Type of glove used for intrapartum vaginal exams
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

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