NCT01852188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
507

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 13, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2014

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

3.5 years

First QC Date

April 18, 2012

Last Update Submit

May 15, 2018

Conditions

Chorioamnionitis

Keywords

IntrapartumGloveChorioamnionitis

Outcome Measures

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

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

Study Arms (2)

Nonsterile

OTHER

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

Other: Type of glove used for intrapartum vaginal exams

Sterile

OTHER

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

Other: Type of glove used for intrapartum vaginal exams

Interventions

Type of glove used for intrapartum vaginal examsOTHER

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

NonsterileSterile

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications to labor
  • Multiple gestations
  • Rupture of Membranes greater than 12 hours
  • Gestational age less than 34 weeks
  • Non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Chorioamnionitis

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Laura Houston, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Donna Johnson

    Medical University of South Carolina, Obstetrics-Gynecology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

May 13, 2013

Study Start

May 1, 2011

Primary Completion

November 2, 2014

Study Completion

November 2, 2014

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

US(1)