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Recruiting NCT05754645

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

— Observational Obesity, Maternal Pregnancy Complications Gut Microbiota

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood withdrawal.
Who it may be relevant to
Registry conditions: Obesity, Maternal, Pregnancy Complications, Gut Microbiota. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The PROMOTE Study, a Pilot: The Characterization of the Microbiome in Pregnancy and Prediction of Pregnancy Outcomes

Overview

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

Detailed description

With the increasing global prevalence of obesity, pregnancy problems related to maternal obesity are increasingly occurring. Microbial gut symbiosis plays an important role in health, with dysbiosis being associated with diseases such as obesity. Of interest are pregnancy, dietary patterns and pre- or probiotics that affect the composition of the gut microbiome. The microbiome itself can influence many physiological processes, such as immune responses (production of microbial products) and the nutrient-dependent one-carbon metabolism. It is hypothesized that gut dysbiosis, due to maternal obesity, during pregnancy can be considered an endogenous chronic stressor causing impaired immune response and carbon metabolism. Both processes result in excessive oxidative stress, detrimental to cell replication, differentiation and epigenetic programming of maternal and infant tissues. Together, these biological disturbances contribute to placental and vascular dysfunction, leading to an increased risk of preeclampsia or gestational diabetes mellitus. Vertical (during pregnancy) and horizontal (during delivery) transmission of gut dysbiosis from mother to newborn and epigenetic placental and foetal changes may ultimately lead to macrosomia and obesity in children. Therefore, the differences between the gut and vaginal microbiome, maternal and fetal immune responses and one-carbon metabolism in obese versus normal-weight pregnant women will be analysed.

Interventions

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

Primary outcome measures

  • Gut and vaginal microbiota [Time frame: Preconceptional (up to 1 year before pregnancy)]
  • Gut and vaginal microbiota [Time frame: First trimester (between 7-12 weeks gestational age)]
  • Gut and vaginal microbiota [Time frame: Second trimester (between 22-25 weeks gestational age)]
  • Gut and vaginal microbiota [Time frame: Third trimester (between 30-32 weeks gestational age)]
  • Gut and vaginal microbiota [Time frame: Antepartum (during delivery)]
  • Gut and vaginal microbiota [Time frame: Postpartum (6-8 weeks post delivery)]
Secondary outcome measures (12)
  • Gut virome [Time frame: Preconceptional (up to 1 year before pregnancy)]
  • Gut virome [Time frame: First trimester (between 7-12 weeks gestational age)]
  • Gut virome [Time frame: Second trimester (between 22-24 weeks gestational age)]
  • Gut virome [Time frame: Third trimester (between 30-32 weeks gestational age)]
  • Gut virome [Time frame: Antepartum (during delivery)]
  • Gut virome [Time frame: Postpartum (6-8 weeks post delivery)]
  • Maternal immune response [Time frame: Preconceptional (up to 1 year before pregnancy)]
  • Maternal immune response [Time frame: First trimester (between 7-12 weeks gestational age)]
  • Maternal immune response [Time frame: Second trimester (between 22-24 weeks gestational age)]
  • Maternal immune response [Time frame: Third trimester (between 30-32 weeks gestational age)]
  • Maternal immune response [Time frame: Antepartum (during delivery)]
  • Maternal immune response [Time frame: Postpartum (6-8 weeks post delivery)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Erasmus MC — Rotterdam

Publications

  • 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 avail PMID 34097026
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05754645 · NL80155.078.22/OZBS72.21318

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗