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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01852188
Other study ID # HR 20638
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Terminated NCT03320785 - Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Withdrawn NCT02886910 - Chorioamnionitis: Observation of at Risk Infants vs Standard Care N/A
Completed NCT01633294 - Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term Phase 2/Phase 3
Recruiting NCT00299637 - Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis Phase 0
Completed NCT00153517 - Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy Phase 2
Completed NCT00397735 - N-acetylcysteine in Intra-amniotic Infection/Inflammation Phase 1/Phase 2
Completed NCT00814905 - Treatment of Chorioamnionitis After Delivery N/A
Completed NCT00879190 - Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis Phase 2/Phase 3
Recruiting NCT04307069 - Management of Prelabor Rupture of the Membranes at Term N/A
Withdrawn NCT03168178 - Intrapartum Fever: Antibiotics Versus no Treatment Phase 4
Completed NCT03576560 - Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
Completed NCT00185991 - Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis N/A
Completed NCT00070746 - Perinatal Infections in Pakistan N/A
Completed NCT03636698 - Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway
Not yet recruiting NCT01778725 - Early Identification of Brain Insult in Chorioamnionitis N/A
Recruiting NCT01988168 - Closure of Skin in ChorioAmnionitis Research Pilot Study N/A
Completed NCT04651309 - Assessment of Labour Progress by Intrapartum Ultrasound N/A
Completed NCT00724594 - Safety of N-acetylcysteine in Maternal Chorioamnionitis (NAC in Chorio) Phase 1/Phase 2