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

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Erasmus University

Status

Enrolling

Conditions

Obesity, Maternal
Pregnancy Complications
Gut Microbiota

Treatments

Other: Blood withdrawal

Study type

Observational

Funder types

Other

Identifiers

NCT05754645
NL80155.078.22/OZBS72.21318

Details and patient eligibility

About

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

Full 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.

Enrollment

110 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

110 participants in 1 patient group

110 women
Description:
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
Treatment:
Other: Blood withdrawal

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Nicole Schenkelaars, MD

Data sourced from clinicaltrials.gov

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