The Ome-study, a pilot: the logistics and characterization of a placental, neonatal and (fe)male periconceptional microbiome, virome and metabolome
Withdrawn
- Conditions
- periconceptional periodperiod around the beginning of pregnancy10010273
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1) Part 1a: Men and women >= 18 and 45 <= years of age, healthy and in the
periconceptional period or couples contemplating pregnancy and visiting the
preconception and reproductive life planning clinics at the Erasmus MC.
2) Part 1b: Women >= 18 and 45 <= years of age who will undergo an elective term
caesarean section.
3) Understanding of Dutch in speaking and reading.
4) Part 1a: Willingness to undergo a speculum examination (female) or produce a
semen specimen (male).
5) Written informed consent.
Exclusion Criteria
1) Men and women unable or unwilling to agree with the physical examination and
procedures.
2) Men and women unable or unwilling to give written informed consent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To establish a functional work protocol for analyzing, characterization and<br /><br>determination of the periconceptional, placental and neonatal microbiome and<br /><br>metabolome.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>