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Could expressing milk before birth help preterm babies?

NCT ID NCT07191366

Symptom relief Sponsor: Odense University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study looks at whether pregnant women at high risk of preterm birth can safely express breastmilk from week 28 to 34 of pregnancy. Researchers will check if it affects how soon the baby is born, how much milk is available at birth, and whether it helps with breastfeeding. The goal is to see if this simple technique can give preterm newborns better access to their mother's milk.

What this could mean

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

Active substance
Hand stimulation of the breast (antenatal breastmilk expression)
What this could lead to
If it works, this could give preterm babies earlier access to their mother's milk, potentially improving nutrition and breastfeeding success.
What could go wrong
This is an early-stage study with 250 participants, so results may not apply to all high-risk pregnancies. There is a small risk that expressing milk could trigger contractions or other complications.

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 250 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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

Female participants only

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: * Pregnant women with a GA between 28 weeks and 0 days and 34 weeks and 0 days who are either diagnosed with preeclampsia or PPROM or have previously given birth before 34 weeks of gestation * Resident in the Region of Southern Denmark * Women speaking and understanding Danish or English * Planning to breastfeed their infants Exclusion Criteria: * HELLP or severe preeclampsia indicating expected induction of labour/caesarean section within a few days (According to national guidelines) * Chorioamnionitis indicating induction of labour/caesarean section within a few days * Women with a vaginal cerclage and PPROM * Women taking medications contraindicating breastfeeding * Women with prior breast reductive surgery or mastectomy * Below 18 years of age * Contractions to a certain extend expecting delivery within a few days * Included in other trials, where breastfeeding is among outcomes

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Conditions

The condition(s) this trial relates to.

preeclampsia Premature Birth preterm premature rupture of the membranes

As listed by the trial registrant

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

PPROM Preeclampsia Preterm birth Previous preterm birth

How to take part

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  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.