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

NCT05754645 | Recruiting DMC

• 1 other identifier: NL80155.078.22/OZBS72.21318
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Maternal; Pregnancy Complications; Gut Microbiota

Outcome Measures

Primary Outcomes (6)

• 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).

  Preconceptional (up to 1 year before pregnancy)

• 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.

  First trimester (between 7-12 weeks gestational age)

• 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.

  Second trimester (between 22-25 weeks gestational age)

• 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.

  Third trimester (between 30-32 weeks gestational age)

• 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.

  Antepartum (during delivery)

• 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.

  Postpartum (6-8 weeks post delivery)

Secondary Outcomes (59)

• Gut virome

  Preconceptional (up to 1 year before pregnancy)

• Gut virome

  First trimester (between 7-12 weeks gestational age)

• Gut virome

  Second trimester (between 22-24 weeks gestational age)

• Gut virome

  Third trimester (between 30-32 weeks gestational age)

• Gut virome

  Antepartum (during delivery)

Study Arms (1)

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

Other: Blood withdrawal

Interventions

Blood withdrawal OTHER

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

Also known as: Vaginal/rectal swabs

110 women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Related Publications (11)

• 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.

  PMID: 34097026 BACKGROUND

• 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.

  PMID: 23784909 BACKGROUND

• 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.

  PMID: 26002170 BACKGROUND

• 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.

  PMID: 18331423 BACKGROUND

• Tanvig M. Offspring body size and metabolic profile - effects of lifestyle intervention in obese pregnant women. Dan Med J. 2014 Jul;61(7):B4893.

  PMID: 25123127 BACKGROUND

• 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.

  PMID: 30006584 BACKGROUND

• 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.

  PMID: 24578535 BACKGROUND

• 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.

  PMID: 29968760 BACKGROUND

• 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.

  PMID: 31523266 BACKGROUND

• 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.

  PMID: 19043404 BACKGROUND

• 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.

  PMID: 40173397 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Vaginal sample (swab) Rectal sample (swab)

MeSH Terms

Conditions

Pregnancy in Obesity; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicole Schenkelaars, MD

CONTACT

+31627530793; n.schenkelaars@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, gynecologist-perinatologist

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: March 6, 2023
• Study Start: July 21, 2022
• Primary Completion: August 21, 2025
• Study Completion (Estimated): August 21, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)