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NCT03576560 Clinical Trial

Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis

Chorioamnionitis Clinical Trial

— Chorio  

Official title:
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03576560
Other study ID # 16NE-Z035-6145
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 26, 2017
Est. completion date May 1, 2019

Study information
Verified date June 2019
Source Mednax Center for Research, Education, Quality and Safety
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis

Description:

To determine the incidence and types of adverse outcomes in infants born to mothers with signs of chorioamnionitis when these infants are asymptomatic and are not treated with antibiotics empirically.

Recruitment information / eligibility
Status Completed
Enrollment 768
Est. completion date May 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 35 Weeks to 42 Weeks
Eligibility Inclusion Criteria:

• Mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician)

Exclusion Criteria: None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Retrospective Chart Review
Retrospective Chart Review

Locations
Country Name City State
United States Women's Hospital of Greensboro Greensboro North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infants born to mother with chorioamnionitis/intrapartum fever as assessed by chart review. The retrospective chart review would analyze the total number of infants born to mothers with chorioamnionitis/intrapartum fever. Infants born from July, 2012 to December 31, 2018.
See also
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Recruiting NCT00299637 - Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis Phase 0
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Completed NCT00814905 - Treatment of Chorioamnionitis After Delivery N/A
Completed NCT01852188 - Intrapartum Study of Sterile and Clean Gloves 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 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