ChorioamnionitisChorioNCT03576560
Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
An observational study of Chorioamnionitis, run by Pediatrix at 1 site in United States.
Trial summary
Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis Read more about this study
- Who is it for?
- Ages 35 to 42 weeks, women only
- Conditions the study is for
- Chorioamnionitis
- What is being tested?
- Retrospective Chart Review
- How many people
- 768 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 weeks
- Women only
- No healthy volunteers
- Child
Study population: Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR was implemented), to present.
Who may be able to join
- Mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Hospital of Greensboro
Greensboro, North Carolina, 27408-7079
About this study
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
- Chorioamnionitis
- Being tested
- Retrospective Chart Review
- Medical subject headings
- Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Chart ReviewOther
Retrospective Chart Review
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Infants born from July, 2012 to December 31, 2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start26 Jun 2017
- Primary completion1 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 768 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Wimmer, MD, Principal investigator, MEDNAX Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576560
- Sponsor's protocol ID
- 16NE-Z035-6145
- Acronym
- Chorio
- Status last verified
- May 2025
- First submitted
- 26 Jun 2018
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Use of Antibiotics in Neonates Born to Mothers With Suspected Chorioamnionitis
- ClinicalTrials.gov ID
- NCT03576560
- Acronym / sponsor ID
- Chorio / 16NE-Z035-6145
- Conditions
- Chorioamnionitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 768 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective Chart Review to determine the selective use of antibiotics in neonates born to mothers with suspected chorioamnionitis
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients born at Women's Hospital/Cone Health in Greensboro, NC, from July, 2012 (when EMR was implemented), to present.
Key inclusion criteria (1 listed)
- Mother/baby dyads in which the mother was diagnosed with chorioamnionitis and/or had intrapartum fever (as diagnosed by obstetrician)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Chart ReviewRetrospective Chart Review | Other | – |
Primary outcome
Infants born to mother with chorioamnionitis/intrapartum fever as assessed by chart review.
Time frame: Infants born from July, 2012 to December 31, 2018.
The retrospective chart review would analyze the total number of infants born to mothers with chorioamnionitis/intrapartum fever.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
Related trials for Chorioamnionitis
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Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo
Meconium-stained Amniotic Fluid, Chorioamnionitis
Active, not recruitingObservational study
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Fetal Infection, Fetal Inflammatory Response Syndrome
Enrolling by invitation
Planned Early Induction of Labor vs Expectant Management for PROM
Premature Rupture of Membranes (PROM)
Active, not recruitingObservational study
Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes
Intrapartum Maternal Fever, Clinical Chorioamnionitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Wimmer, MD principal investigator
MEDNAX Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chorioamnionitis, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infants born to mother with chorioamnionitis/intrapartum fever as assessed by chart review. (time frame: Infants born from July, 2012 to December 31, 2018.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.