Amniotic fluid and the extremely preterm baby's gut

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective cohort will collect about 5 mL of amniotic fluid from 125 deliveries at gestational ages 24+0 to 27+6 weeks at Amsterdam UMC and Máxima Medical Center. Samples will be obtained during vaginal delivery or cesarean section and analyzed using advanced molecular, metabolomic, and microbiome techniques to characterize fluid composition. Secondary analyses will compare amniotic fluid profiles in cases with maternal chorioamnionitis or fetal growth restriction, examine key metabolites across gestation, and correlate amniotic fluid signatures with neonatal outcomes and early gut microbiota. No interventions are given; the project is observational and aims to identify biomarkers and biological signals linked to NEC and neonatal sepsis risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Maternal age ≥16 years
* Written informed consent
* Successful collection of amniotic fluid

Exclusion Criteria:

* Pregnancies complicated by fetal congenital and/or chromosomal abnormalities.
* Insufficient proficiency of Dutch or English language

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Máxima Medical Center
  Veldhoven, Netherlands Recruiting

Study contacts

• Study coordinator: Mirjam M. van Weissenbruch
• Email: m.vanweissenbruch@amsterdamumc.nl
• Phone: 020 566 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.