The PROMOTE Study, a Pilot: The Characterization of the Microbiome in Pregnancy and Prediction of Pregnancy Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Maternal
- Sponsor
- Erasmus Medical Center
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Gut and vaginal microbiota
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Sam Schoenmakers
Principal Investigator, gynecologist-perinatologist
Erasmus Medical Center
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
- •Gastro-intestinal diseases, heart diseases, liver, pancreas and kidney diseases.
- •Use of antibiotics \< 2 weeks before sampling
- •Pre-existent diabetes mellitus
Outcomes
Primary Outcomes
Gut and vaginal microbiota
Time Frame: Postpartum (6-8 weeks post delivery)
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.
Secondary Outcomes
- Gut virome(Postpartum (6-8 weeks post delivery))
- Clinical maternal outcome: gestational age(Durante partum)
- Clinical maternal outcome: pre-eclampsia(from 20 weeks of gestation to <8 weeks postpartum)
- Fetal growth(Third trimester (Between 30-33 weeks of gestational age))
- Maternal immune response(Postpartum (6-8 weeks post delivery))
- Maternal metabolic response(Postpartum (6-8 weeks post delivery))
- Clinical maternal outcome: hypertension(from 20 weeks of gestation to <8 weeks postpartum)
- Clinical maternal outcome: gestational diabetes(From the first positive pregnancy test to delivery)
- Histological placental function(Postpartum (<2 days postpartum))
- Placental weight(Postpartum (<2 days postpartum))