The Microbiome in (Non-) Obese Pregnancy and Pregnancy Outcomes
NCT ID: NCT05754645
Last Updated: 2024-09-19
Study Results
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Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2022-07-21
2026-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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110 women
60 women with a BMI between 18,5-25 kg/m2, of which 10 preconceptional 60 women with a BMI \> 30 kg/m2, of which 10 preconceptional
Blood withdrawal
venous punction with blood withdrawal Vaginal and rectal swab, done by patient itself
Interventions
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Blood withdrawal
venous punction with blood withdrawal Vaginal and rectal swab, done by patient itself
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* ≥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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Sam Schoenmakers
Principal Investigator, gynecologist-perinatologist
Locations
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Erasmus MC
Rotterdam, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Rousian M, Schoenmakers S, Eggink AJ, Gootjes DV, Koning AHJ, Koster MPH, Mulders AGMGJ, Baart EB, Reiss IKM, Laven JSE, Steegers EAP, Steegers-Theunissen RPM. Cohort Profile Update: the Rotterdam Periconceptional Cohort and embryonic and fetal measurements using 3D ultrasound and virtual reality techniques. Int J Epidemiol. 2021 Nov 10;50(5):1426-1427l. doi: 10.1093/ije/dyab030. No abstract available.
Gaillard R, Durmus B, Hofman A, Mackenbach JP, Steegers EA, Jaddoe VW. Risk factors and outcomes of maternal obesity and excessive weight gain during pregnancy. Obesity (Silver Spring). 2013 May;21(5):1046-55. doi: 10.1002/oby.20088.
Mission JF, Marshall NE, Caughey AB. Pregnancy risks associated with obesity. Obstet Gynecol Clin North Am. 2015 Jun;42(2):335-53. doi: 10.1016/j.ogc.2015.01.008.
Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008 Sep;9(5):474-88. doi: 10.1111/j.1467-789X.2008.00475.x. Epub 2008 Mar 5.
Tanvig M. Offspring body size and metabolic profile - effects of lifestyle intervention in obese pregnant women. Dan Med J. 2014 Jul;61(7):B4893.
Kuhle S, Muir A, Woolcott CG, Brown MM, McDonald SD, Abdolell M, Dodds L. Maternal pre-pregnancy obesity and health care utilization and costs in the offspring. Int J Obes (Lond). 2019 Apr;43(4):735-743. doi: 10.1038/s41366-018-0149-3. Epub 2018 Jul 13.
Morgan KL, Rahman MA, Macey S, Atkinson MD, Hill RA, Khanom A, Paranjothy S, Husain MJ, Brophy ST. Obesity in pregnancy: a retrospective prevalence-based study on health service utilisation and costs on the NHS. BMJ Open. 2014 Feb 27;4(2):e003983. doi: 10.1136/bmjopen-2013-003983.
Elderman M, Hugenholtz F, Belzer C, Boekschoten M, de Haan B, de Vos P, Faas M. Changes in intestinal gene expression and microbiota composition during late pregnancy are mouse strain dependent. Sci Rep. 2018 Jul 3;8(1):10001. doi: 10.1038/s41598-018-28292-2.
Schoenmakers S, Steegers-Theunissen R, Faas M. The matter of the reproductive microbiome. Obstet Med. 2019 Sep;12(3):107-115. doi: 10.1177/1753495X18775899. Epub 2018 May 17.
Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30.
Schenkelaars N, Wekema L, Faas MM, Steegers-Theunissen RPM, Schoenmakers S. Protocol of the PROMOTE study: characterization of the microbiome, the immune response, and one-carbon metabolism in preconceptional and pregnant women with and without obesity (an observational subcohort of the Rotterdam Periconception cohort). PLoS One. 2025 Apr 2;20(4):e0319618. doi: 10.1371/journal.pone.0319618. eCollection 2025.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NL80155.078.22/OZBS72.21318
Identifier Type: -
Identifier Source: org_study_id
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