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Intrapartum Study of Sterile and Clean Gloves

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ClinicalTrials.gov Identifier: NCT01852188
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chorioamnionitis Other: Type of glove used for intrapartum vaginal exams Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial
Actual Study Start Date : May 2011
Actual Primary Completion Date : November 2, 2014
Actual Study Completion Date : November 2, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Nonsterile
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
Other: Type of glove used for intrapartum vaginal exams
Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

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




Primary Outcome Measures :
  1. Clinical chorioamnionitis [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852188


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Laura Houston, MD Medical University of South Carolina
Study Chair: Donna Johnson Medical University of South Carolina, Obstetrics-Gynecology
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01852188    
Other Study ID Numbers: HR 20638
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Keywords provided by Medical University of South Carolina:
Intrapartum
Glove
Chorioamnionitis
Additional relevant MeSH terms:
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Chorioamnionitis
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases