An observational study in Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn and Necrotizing Enterocolitis of Newborn, sponsored by Maxima Medical Center. Recruiting at 2 sites in Netherlands. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Maxima Medical Center · Observational
Background:
Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and/or fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota.
Methods:
ln this multicenter, prospective, cohort study, AF (\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0/7-27+6/7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \<23+/7 weeks), very early and moderate to late preterm (GA 28+0/6-36+6/7 weeks), and full-term pregnancies (GA 37+0/7-41+6/7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns.
Discussion and expected results:
AF profiles associated with CAM and/or FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's planned enrollment of 275 is above the median of 125 across 14 observational studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →Maxima Medical Center is the lead sponsor of 29 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants included in the study group must be born between 24+0/7 and 27+6/7 weeks. AF samples are also collected from a reference group, including early midtrimester (GA ≤23+6/7 weeks), very and moderate to late preterm (GA 28+0/7-36+6/7 weeks), and full-term pregnancies (GA 37+0/7-41+6/7 weeks).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total cohort consists of: 1) study group - gestational age 24+0/7-27+6/7 weeks, 2) reference/control group: \<24+0/7 weeks and 28+0/7-40+6/7 weeks
AF & preterm birth
Microbial \& metabolic composition of amniotic fluid in extremely preterm birth
Time frame: Baseline
AF profiles & chorioamnionitis
Characterizion of AF profiles in infants exposed to chorioamnionitis
Time frame: Baseline
AF & fetal growth restriction
Characterizion of AF profiles in infants with fetal growth restriction
Time frame: Baseline
AF & neonatal gut microbiota
To correlate composition of amniotic fluid to neonatal gut microbiota in first month of life
Time frame: For AF baseline measurement, for neonatal gut microbiota composition at t=0, t=7, t=14, t=21, and t=28 (postnatal days)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.
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