NL-OMON56939
Not yet recruiting
Not Applicable
The impact of amniotic fluid on the development and microbial colonization of the preterm intestinal tract: the AMFIBIE study - Amniotic fluid and preterm gut health: the AMFIBIE study
Máxima Medisch Centrum0 sites275 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Máxima Medisch Centrum
- Enrollment
- 275
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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Unknown
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