Clinical trial

The Microbiome in (Non-) Obese Pregnancy and Pregnancy Outcomes

Recruiting now · Not applicable · 1 countries · Registry ID NCT05754645

Recruiting nowNot applicableObservational

What this study is about

This research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity, Maternal, Pregnancy Complications, Gut Microbiota

Full registry criteria

Inclusion Criteria: * Participation in Predict study * Preconceptional women who wish to become pregnant or pregnancy \<13 weeks of gestational age. * BMI \> 30 kg/m2 or 18-25 kg/m2 * Understanding of Dutch in speaking and reading * Willingness to give written informed consent Exclusion Criteria: * Age \< 18 years and \> 45 years. * ≥13 weeks of gestational age * Multiple pregnancy * Smoking * Gastro-intestinal diseases, heart diseases, liver, pancreas and kidney diseases. * Use of antibiotics \< 2 weeks before sampling * Pre-existent diabetes mellitus

Treatments and study arms

Blood withdrawal

Other

venous punction with blood withdrawal Vaginal and rectal swab, done by patient itself

Primary outcomes

Gut and vaginal microbiotaPreconceptional (up to 1 year before pregnancy)

Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16S ribosomal ribonucleic acid (16SrRNA) gene amplification sequencing (V6-V8). Sequences will be assigned to operational taxonomic units (OTUs).

Gut and vaginal microbiotaFirst trimester (between 7-12 weeks gestational age)