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Personalized treatment for early water breaking could extend pregnancy safely

NCT ID NCT07107477

Disease control Sponsor: The Central and Eastern European Gynecologic Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial investigates whether using a lab test (IL-6) from amniotic fluid to guide antibiotic and steroid treatment can safely prolong pregnancy in people whose water breaks too early (preterm premature rupture of membranes, or pPROM). Participants are randomly assigned to either standard care or a tailored approach where weekly amniocentesis measures IL-6 levels to decide when to give steroids and antibiotics. The study aims to see if this personalized strategy helps the pregnancy last more than 7 days after pPROM and improves outcomes for both parent and baby.

What this could mean

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

Active substance
amniocentesis-guided tailored antibiotic and steroid therapy
What this could lead to
If successful, this approach could help doctors time treatments better, reduce unnecessary medication, and safely extend pregnancy after early water breaking.
What could go wrong
This is a Phase 3 trial with 138 participants, so results may not apply to all. Amniocentesis carries small risks like infection or cramping, and the tailored strategy may not improve outcomes over standard care.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 138 people

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

Started

May 2025

Expected to finish

May 2028

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: * pPPROM Confirmed by Amnisure test1 and/or clinical signs of pPROM on examination (Clinical signs of pPROM: presence of visual pooling of amniotic fluid during sterile speculum examination) * Weeks of pregnancy 22+03 - 33+64 * Singleton pregnancy * Signed informed consent form (ICF) * Completely uncomplicated pregnancy until the occurrence of pPROM Exclusion Criteria: * active labour (uterine activity leading to cervical dilatation greater than 4 cm) * Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress * Multiple pregnancy * Pregnancy with chromosomal or severe morphological abnormality * Signs of chorioamnionitis at the admission (clinical and/or laboratory) * Patients with severe immunological compromise (immunodeficient) * Patients with an oncological disease/immunosuppression * Patients with an active drug abuse * Non-compliant patients * Any contraindication according to the valid SmPC for the administered product

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Conditions

The condition(s) this trial relates to.

preterm premature rupture of the membranes

As listed by the trial registrant

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

Preterm premature rupture of membranes (pprom)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • General University Hospital in Prague

    RECRUITING

    Prague, 128 08, Czechia

  • Institute for Mother and Child Care in Prague - Podolí

    RECRUITING

    Prague, Czechia

    Contact Email: •••••@•••••

  • University Hospital Brno

    RECRUITING

    Brno, Czechia

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