NCT03576560

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
768

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

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

June 26, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

June 26, 2018

Last Update Submit

May 28, 2025

Conditions

Chorioamnionitis

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Retrospective Chart ReviewOTHER

Retrospective Chart Review

Eligibility Criteria

Age35 Weeks - 42 Weeks
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMother/baby in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR was implemented), to present.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Hospital of Greensboro

Greensboro, North Carolina, 27408-7079, 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

  • John Wimmer, MD

    MEDNAX Employee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 3, 2018

Study Start

June 26, 2017

Primary Completion

March 1, 2019

Study Completion

May 1, 2019

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations

US(1)