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Amniotic Fluid & the Preterm Gut

The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07152106
Acronym
AMFIBIE
Enrollment
275
Registered
2025-09-03
Start date
2024-10-14
Completion date
2027-10-14
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Fetal Growth Restriction (FGR), Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset, Neonatal Sepsis, Late-Onset, Prematurity Complications, Preterm Birth Complication

Brief summary

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.

Interventions

None listed

Sponsors

Maxima Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
AF & preterm birthBaselineMicrobial & metabolic composition of amniotic fluid in extremely preterm birth

Secondary

MeasureTime frameDescription
AF profiles & chorioamnionitisBaselineCharacterizion of AF profiles in infants exposed to chorioamnionitis
AF & fetal growth restrictionBaselineCharacterizion of AF profiles in infants with fetal growth restriction
AF & neonatal gut microbiotaFor AF baseline measurement, for neonatal gut microbiota composition at t=0, t=7, t=14, t=21, and t=28 (postnatal days)To correlate composition of amniotic fluid to neonatal gut microbiota in first month of life

Countries

Netherlands

Contacts

Primary ContactMirjam M. van Weissenbruch
m.vanweissenbruch@amsterdamumc.nl020 566 9111
Backup ContactHendrik Niemarkt, dr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026