CompletedNCT03576560ChorioUpdated Jun 3, 2025

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

An observational study in Chorioamnionitis, sponsored by Pediatrix. Completed at 1 site in United States. Open to female participants aged 35 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Pediatrix · Observational

Study type: Observational
Model: Other
Time perspective: Retrospective
Enrollment: 768
Ages: 35 Weeks to 42 Weeks
Sex: Female

Study summary

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

Read the detailed 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.

Conditions studied

Chorioamnionitis

Browse trials for

Chorioamnionitis 39

In context

Chorioamnionitis

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

This study's enrollment of 768 is above the median of 125 across 14 observational studies indexed under Chorioamnionitis.

Browse Chorioamnionitis studies →

Lead sponsor

Pediatrix is the lead sponsor of 34 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 35 Weeks to 42 Weeks
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Eligibility criteria

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

Observational model: Other
Time perspective: Retrospective
Enrollment: 768 participants (actual)
Patient registry: No

Interventions

OtherRetrospective Chart Review
Retrospective Chart Review

What researchers measure

Primary outcomes

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.
Time frame: Infants born from July, 2012 to December 31, 2018.

Study locations

1 site

Women's Hospital of Greensboro
Greensboro, North Carolina 27408-7079, United States

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Mar 2019, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 26, 2018
First posted: Jul 3, 2018
StartActual: Jun 26, 2017
Primary completionActual: Mar 1, 2019
CompletionActual: May 1, 2019
Last update: Jun 3, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03576560
Lead sponsor: Pediatrix
Responsible party: Sponsor
First posted: Jul 3, 2018
Start date: Jun 26, 2017
Primary completion: Mar 1, 2019
Completion: May 1, 2019
Last update: Jun 3, 2025

Study contacts

John Wimmer, MD

principal investigator · MEDNAX Employee

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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