The impact of amniotic fluid on the development and microbial colonization of the preterm intestinal tract: the AMFIBIE study

• Conditions: Prematurity; preterm birth; 10028920

• Registration Number: NL-OMON56939
• Lead Sponsor: Máxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 275

Inclusion Criteria

Amniotic fluid will be collected from the study population consisting of
obstetric patients delivering their infants extremely preterm (pregnancy
duration between 24 + 0 - 27 + 6/7 weeks) (n = 125) and from a reference cohort
(respectively, early midtrimester (< 24 weeks), very preterm to moderate and
late preterm (28 + 0 - 36 + 6/7 weeks), and full term pregnancies (37 + 0 - 41
+ 6/7 weeks) (n = 150).

Inclusion criteria study population: If the obstetric patient is > 16 years of
age and mentally competent, amniotic fluid can be collected at time of
extremely preterm delivery between 24 and 27 + 6/7 weeks of gestation and
informed consent is obtained from the obstetric patient, the participant can be
included in the study.

Inclusion criteria reference cohort: If the obstetric patient is > 16 years of
age and mentally competent and amniotic fluid can be collected during
clinically indicated amniocentesis (during early midtrimester pregnancies) or
at time of delivery, by means of vaginal delivery or cesarean section, in very
to moderate and late preterm pregnancies or full term pregnancies, the
participant can be included in the study.

Exclusion Criteria

Exclusion criteria study population: Obstetric patients < 16 years of age
and/or mentally incompetent or with pregnancies complicated with major fetal
congenital or chromosomal comorbidities will be excluded from the study.

Exclusion criteria reference population: Obstetric patients < 16 years of age
and/or mentally incompetent or with pregnancies complicated with major fetal
congenital or chromosomal comorbidities will be excluded from the study.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome is the characterization of the bacterial and metabolic<br /><br>composition of AF derived from obstetric patients delivering their infants<br /><br>extremely preterm using advanced biomedical techniques. </p><br>