The Microbiome in (Non-) Obese Pregnancy and Pregnancy Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorErasmus Medical Center
About this trial
This research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years and > 45 years.
≥13 weeks of gestational age
Multiple pregnancy
Smoking
Trial population
This pilot study is embedded in the Rotterdam Periconceptional Cohort study (Predict study). The Predict study population includes preconceptional or pregnant women \> 18 years and \< 45 years old visiting the Erasmus MC and that are willing to participate. We will select the participants, that meet our undermentioned inclusion criteria, for our study from this cohort: 50 women with a BMI \> 30 kg/m2 (cases) and 50 women with a BMI ranging 18-25 kg/m2 (controls) and their neonates. We will longitudinally sample first/2nd/3rd/postpartum, 100 women, in addition we will include 10 preconceptional women with BMI \> 30 kg/m2 and 10 preconceptional women with BMI 18-25 kg/m2, these participants do not necessarily have to conceive a pregnancy in order to remain in the study (these women are part of the preconceptional Predict population).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood withdrawal
Other interventionvenous punction with blood withdrawal Vaginal and rectal swab, done by patient itself
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: 110 women1 intervention
Trial outcomes
Primary outcomes
1
Gut and vaginal microbiota
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).
Time frame
Preconceptional (up to 1 year before pregnancy)2
Gut and vaginal microbiota
Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.
Time frame
First trimester (between 7-12 weeks gestational age)3
Gut and vaginal microbiota
Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.
Time frame
Second trimester (between 22-25 weeks gestational age)4
Gut and vaginal microbiota
Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.
Time frame
Third trimester (between 30-32 weeks gestational age)Secondary outcomes
1
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame
Preconceptional (up to 1 year before pregnancy)2
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame
First trimester (between 7-12 weeks gestational age)3
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame
Second trimester (between 22-24 weeks gestational age)4
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame
Third trimester (between 30-32 weeks gestational age)Sponsors and contacts
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Source ClinicalTrials.gov