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Can a saline flush during labor shield newborn brains?

NCT ID NCT07610642

Disease control Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether infusing fluid into the uterus during labor (amnioinfusion) can reduce brain injury in newborns whose mothers have a uterine infection called chorioamnionitis. The infection can cause inflammation and fever that may stress the baby's brain before birth. Researchers will randomly assign 80 pregnant women with chorioamnionitis to receive either amnioinfusion or standard care, then measure brain injury markers in the baby's umbilical cord blood after delivery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amnioinfusion (lactated ringer's solution infused into the uterus during labor)
What this could lead to
If it works, this could point toward a simple, low-cost way to protect babies' brains during labor when the mother has an infection.
What could go wrong
This is a small, early-stage trial with only 80 participants, so results may not be conclusive. The treatment may not reduce brain injury, and there are always risks with any medical procedure during labor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Maternal age ≥18 years * Singleton gestation * Gestational age ≥36 weeks * Labor at time of enrollment * Clinical chorioamnionitis or intra-amniotic infection defined according to ACOG criteria, including: Maternal temperature ≥38.0°C At least one associated clinical finding, including: * 1\. Maternal leukocytosis * 2\. Purulent cervical drainage * 3\. Fetal tachycardia * Cervical dilation sufficient for intrauterine pressure catheter placement * Ability to provide informed consent Exclusion Criteria: * Multifetal gestation * Known major fetal anomaly * Contraindication to vaginal delivery * Placenta previa * Category III fetal heart tracing requiring immediate delivery * Non-English-speaking

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Conditions

The condition(s) this trial relates to.

chorioamnionitis perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amnioinfusion Chorioamnionitis affecting fetus or newborn Neonatal brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Froedtert Hospital and Medical College of Wisconsin Birth Center

    Milwaukee, Wisconsin, 53045, United States

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