ClinicalTrials.gg
CompletedNCT01852188Updated May 18, 2018

Intrapartum Study of Sterile and Clean Gloves

An interventional study of Type of glove used for intrapartum vaginal exams in Chorioamnionitis, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled May 2011, registered Apr 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
507
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Chorioamnionitis

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Keywords

  • Intrapartum
  • Glove
  • Chorioamnionitis
03

In context

Chorioamnionitis

39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.

This study's enrollment of 507 is above the median of 157 across 22 interventional studies indexed under Chorioamnionitis.

Browse Chorioamnionitis studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.

Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • to labor
  • Multiple gestations
  • Rupture of Membranes greater than 12 hours
  • Gestational age less than 34 weeks
  • Non-English speaking patients
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
507 participants (actual)

Study arms

  • Other
    Nonsterile

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

    Other: Type of glove used for intrapartum vaginal exams

  • Other
    Sterile

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

    Other: Type of glove used for intrapartum vaginal exams

Interventions

  • OtherType of glove used for intrapartum vaginal exams

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: participants will be followed during their intrapartum hospital stay, an expected average of 48-72hrs

07

Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01852188
Responsible party
Sponsor
First posted
May 13, 2013
Start date
May 2011
Primary completion
Nov 2, 2014
Completion
Nov 2, 2014
Last update
May 18, 2018

Study contacts

Laura Houston, MD
principal investigator · Medical University of South Carolina
Donna Johnson
study chair · Medical University of South Carolina, Obstetrics-Gynecology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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