| NCT ID | NCT07152106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxima Medical Center |
| Condition | Chorioamnionitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 275 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2026-10-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 275 participants in total. It began in 2024-10-14 with a primary completion date of 2026-10-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07152106 clinical trial?
This trial is open to female participants only, aged 16 Years or older, studying Chorioamnionitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07152106 currently recruiting?
Yes, NCT07152106 is actively recruiting participants. Contact the research team at m.vanweissenbruch@amsterdamumc.nl for enrollment information.
Where is the NCT07152106 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Veldhoven, Netherlands.
Who is sponsoring the NCT07152106 clinical trial?
NCT07152106 is sponsored by Maxima Medical Center. The trial plans to enroll 275 participants.