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NCT Number: NCT05754645

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

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood withdrawal

Other

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

Other names: Vaginal/rectal swabs

Primary outcomes

  1. Gut and vaginal microbiota

    Time frame: Preconceptional (up to 1 year before pregnancy)

    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).

  2. Gut and vaginal microbiota

    Time frame: First trimester (between 7-12 weeks gestational age)

    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.

  3. Gut and vaginal microbiota

    Time frame: Second trimester (between 22-25 weeks gestational age)

    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.

  4. Gut and vaginal microbiota

    Time frame: Third trimester (between 30-32 weeks gestational age)

    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.

  5. Gut and vaginal microbiota

    Time frame: Antepartum (during 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.

  6. 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

  1. Gut virome

    Time frame: Preconceptional (up to 1 year before pregnancy)

    Composition of gut virome, obtained by a rectal swab

  2. Gut virome

    Time frame: First trimester (between 7-12 weeks gestational age)

    Composition of gut virome, obtained by a rectal swab

  3. Gut virome

    Time frame: Second trimester (between 22-24 weeks gestational age)

    Composition of gut virome, obtained by a rectal swab

  4. Gut virome

    Time frame: Third trimester (between 30-32 weeks gestational age)

    Composition of gut virome, obtained by a rectal swab

  5. Gut virome

    Time frame: Antepartum (during delivery)

    Composition of gut virome, obtained by a rectal swab

  6. Gut virome

    Time frame: Postpartum (6-8 weeks post delivery)

    Composition of gut virome, obtained by a rectal swab

  7. Maternal immune response

    Time frame: Preconceptional (up to 1 year before pregnancy)

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

  8. Maternal immune response

    Time frame: First trimester (between 7-12 weeks gestational age)

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

  9. Maternal immune response

    Time frame: Second trimester (between 22-24 weeks gestational age)

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

  10. Maternal immune response

    Time frame: Third trimester (between 30-32 weeks gestational age)

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

  11. Maternal immune response

    Time frame: Antepartum (during delivery)

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

  12. Maternal immune response

    Time frame: Postpartum (6-8 weeks post delivery)

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

  13. Maternal immune response

    Time frame: Preconceptional (up to 1 year before pregnancy)

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  14. Maternal immune response

    Time frame: First trimester (between 7-12 weeks gestational age)

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  15. Maternal immune response

    Time frame: Second trimester (between 22-24 weeks gestational age)

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  16. Maternal immune response

    Time frame: Third trimester (between 30-32 weeks gestational age)

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  17. Maternal immune response

    Time frame: Antepartum (during delivery)

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  18. Maternal immune response

    Time frame: Postpartum (6-8 weeks post delivery)

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  19. Maternal immune response

    Time frame: Preconceptional (up to 1 year before pregnancy)

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  20. Maternal immune response

    Time frame: First trimester (between 7-12 weeks gestational age)

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  21. Maternal immune response

    Time frame: Second trimester (between 22-24 weeks gestational age)

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  22. Maternal immune response

    Time frame: Third trimester (between 30-32 weeks gestational age)

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  23. Maternal immune response

    Time frame: Antepartum (during delivery)

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  24. Maternal immune response

    Time frame: Postpartum (6-8 weeks post delivery)

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

  25. Maternal immune response

    Time frame: Preconceptional (up to 1 year before pregnancy)

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

  26. Maternal immune response

    Time frame: First trimester (between 7-12 weeks gestational age)

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

  27. Maternal immune response

    Time frame: Second trimester (between 22-24 weeks gestational age)

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

  28. Maternal immune response

    Time frame: Third trimester (between 30-32 weeks gestational age)

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

  29. Maternal immune response

    Time frame: Antepartum (during delivery)

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

  30. Maternal immune response

    Time frame: Postpartum (6-8 weeks post delivery)

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

  31. Maternal metabolic response

    Time frame: Preconceptional (up to 1 year before pregnancy)

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  32. Maternal metabolic response

    Time frame: First trimester (between 7-12 weeks gestational age)

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  33. Maternal metabolic response

    Time frame: Second trimester (between 22-24 weeks gestational age)

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  34. Maternal metabolic response

    Time frame: Third trimester (between 30-32 weeks gestational age)

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  35. Maternal metabolic response

    Time frame: Antepartum (during delivery)

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  36. Maternal metabolic response

    Time frame: Postpartum (6-8 weeks post delivery)

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  37. Maternal metabolic response

    Time frame: Preconceptional (up to 1 year before pregnancy)

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  38. Maternal metabolic response

    Time frame: First trimester (between 7-12 weeks gestational age)

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  39. Maternal metabolic response

    Time frame: Second trimester (between 22-24 weeks gestational age)

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  40. Maternal metabolic response

    Time frame: Third trimester (between 30-32 weeks gestational age)

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  41. Maternal metabolic response

    Time frame: Antepartum (during delivery)

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  42. Maternal metabolic response

    Time frame: Postpartum (6-8 weeks post delivery)

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  43. Maternal metabolic response

    Time frame: Preconceptional (up to 1 year before pregnancy)

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  44. Maternal metabolic response

    Time frame: First trimester (between 7-12 weeks gestational age)

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  45. Maternal metabolic response

    Time frame: Second trimester (between 22-24 weeks gestational age)

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  46. Maternal metabolic response

    Time frame: Third trimester (between 30-32 weeks gestational age)

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  47. Maternal metabolic response

    Time frame: Antepartum (during delivery)

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  48. Maternal metabolic response

    Time frame: Postpartum (6-8 weeks post delivery)

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

  49. Clinical maternal outcome: gestational age

    Time frame: Durante partum

    Gestational age (amenorrhea duration) at delivery.

  50. Clinical maternal outcome: pre-eclampsia

    Time frame: from 20 weeks of gestation to <8 weeks postpartum

    Pre-eclampsia is defined as the combination of gestational hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg (Korotkoff V) occurring after 20 weeks of gestation gestational age, measured twice, in a woman who previously had normal blood pressure) with proteinuria (≥ 300 mg/24 hours).

  51. Clinical maternal outcome: hypertension

    Time frame: from 20 weeks of gestation to <8 weeks postpartum

    Hypertension is defined as a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg (Korotkoff V) occurring after 20 weeks of gestation gestational age, measured twice, in a woman who previously had normal blood pressure.

  52. Clinical maternal outcome: gestational diabetes

    Time frame: From the first positive pregnancy test to delivery

    Gestational diabetes defined as any form of hyperglycaemia detected during pregnancy, regardless ofwhether this abnormality disappears after pregnancy. Diagnosed through a 75 gr Oral Glucose Tolerance Test (OGTT) with a fasting venous value > 7 mmol/l or above 7.8 mmol/l after 2 hours.

  53. Fetal growth

    Time frame: First trimester (Between 7-7+6 days of gestational age)

    Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.

  54. Fetal growth

    Time frame: First trimester (Between 9-9+6 days of gestational age)

    Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.

  55. Fetal growth

    Time frame: First trimester (Between 11-11+6 days of gestational age)

    Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.

  56. Fetal growth

    Time frame: Second trimester (Between AD 22-25 weeks of gestational age)

    Fetal growth trajectories defined as Estimated Fetal Weight (EFW) (in grams) based on the measurements (in mm) of the Head circumference (HC), Biparietal diameter (BPD), Abdominal circumference (AC) and Femur length (FL) to be obtained/measured during the ultrasound.

  57. Fetal growth

    Time frame: Third trimester (Between 30-33 weeks of gestational age)

    Fetal growth trajectories defined as Estimated Fetal Weight (EFW) (in grams) based on the measurements (in mm) of the Head circumference (HC), Biparietal diameter (BPD), Abdominal circumference (AC) and Femur length (FL) to be obtained/measured during the ultrasound.

  58. Histological placental function

    Time frame: Postpartum (<2 days postpartum)

    Histology of placenta: biopsies are taken within 2 days after delivery, these are snapfrozen in -80 degrees Celsius and assessed according to protocol by pathologist

  59. Placental weight

    Time frame: Postpartum (<2 days postpartum)

    Placental weight measured (in grams), weighed on the scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Schenkelaars, MD

CONTACT

[email protected]

+31627530793

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: PROMOTE

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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