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NCT Number: NCT01852188

Intrapartum Study of Sterile and Clean Gloves

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.

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Key information

Conditions

Chorioamnionitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type of glove used for intrapartum vaginal exams

Other

Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 13, 2013
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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