An observational study in Obesity, Maternal, Pregnancy Complications and Gut Microbiota, sponsored by Erasmus Medical Center. Status unknown at 1 site in Netherlands. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Erasmus Medical Center · Observational
This research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring.
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.
23 studies on the registry are indexed under Pregnancy in Obesity; 10 are open to participants now.
This study's planned enrollment of 110 is below the median of 258 across 10 observational studies indexed under Pregnancy in Obesity.
Browse Pregnancy in Obesity studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
venous punction with blood withdrawal Vaginal and rectal swab, done by patient itself
Also known as: Vaginal/rectal swabs
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postpartum (6-8 weeks post delivery)
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame: Preconceptional (up to 1 year before pregnancy)
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame: First trimester (between 7-12 weeks gestational age)
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame: Second trimester (between 22-24 weeks gestational age)
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame: Third trimester (between 30-32 weeks gestational age)
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame: Antepartum (during delivery)
Gut virome
Composition of gut virome, obtained by a rectal swab
Time frame: Postpartum (6-8 weeks post delivery)
Maternal immune response
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.
Time frame: Preconceptional (up to 1 year before pregnancy)
Maternal immune response
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.
Time frame: First trimester (between 7-12 weeks gestational age)
Maternal immune response
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.
Time frame: Second trimester (between 22-24 weeks gestational age)
Maternal immune response
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.
Time frame: Third trimester (between 30-32 weeks gestational age)
Maternal immune response
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.
Time frame: Antepartum (during delivery)
Maternal immune response
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.
Time frame: Postpartum (6-8 weeks post delivery)
Maternal immune response
Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Preconceptional (up to 1 year before pregnancy)
Maternal immune response
Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: First trimester (between 7-12 weeks gestational age)
Maternal immune response
Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Second trimester (between 22-24 weeks gestational age)
Maternal immune response
Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Third trimester (between 30-32 weeks gestational age)
Maternal immune response
Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Antepartum (during delivery)
Maternal immune response
Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Postpartum (6-8 weeks post delivery)
Maternal immune response
Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Preconceptional (up to 1 year before pregnancy)
Maternal immune response
Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: First trimester (between 7-12 weeks gestational age)
Maternal immune response
Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Second trimester (between 22-24 weeks gestational age)
Maternal immune response
Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Third trimester (between 30-32 weeks gestational age)
Maternal immune response
Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Antepartum (during delivery)
Maternal immune response
Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.
Time frame: Postpartum (6-8 weeks post delivery)
Maternal immune response
high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.
Time frame: Preconceptional (up to 1 year before pregnancy)
Maternal immune response
high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.
Time frame: First trimester (between 7-12 weeks gestational age)
Maternal immune response
high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.
Time frame: Second trimester (between 22-24 weeks gestational age)
Maternal immune response
high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.
Time frame: Third trimester (between 30-32 weeks gestational age)
Maternal immune response
high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.
Time frame: Antepartum (during delivery)
Maternal immune response
high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.
Time frame: Postpartum (6-8 weeks post delivery)
Maternal metabolic response
Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Preconceptional (up to 1 year before pregnancy)
Maternal metabolic response
Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: First trimester (between 7-12 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Second trimester (between 22-24 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Third trimester (between 30-32 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Antepartum (during delivery)
Maternal metabolic response
Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Postpartum (6-8 weeks post delivery)
Maternal metabolic response
Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Preconceptional (up to 1 year before pregnancy)
Maternal metabolic response
Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: First trimester (between 7-12 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Second trimester (between 22-24 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Third trimester (between 30-32 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Antepartum (during delivery)
Maternal metabolic response
Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Postpartum (6-8 weeks post delivery)
Maternal metabolic response
Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Preconceptional (up to 1 year before pregnancy)
Maternal metabolic response
Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: First trimester (between 7-12 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Second trimester (between 22-24 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Third trimester (between 30-32 weeks gestational age)
Maternal metabolic response
Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Antepartum (during delivery)
Maternal metabolic response
Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.
Time frame: Postpartum (6-8 weeks post delivery)
Clinical maternal outcome: gestational age
Gestational age (amenorrhea duration) at delivery.
Time frame: Durante partum
Clinical maternal outcome: pre-eclampsia
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).
Time frame: from 20 weeks of gestation to <8 weeks postpartum
Clinical maternal outcome: hypertension
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.
Time frame: from 20 weeks of gestation to <8 weeks postpartum
Clinical maternal outcome: gestational diabetes
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.
Time frame: From the first positive pregnancy test to delivery
Fetal growth
Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.
Time frame: First trimester (Between 7-7+6 days of gestational age)
Fetal growth
Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.
Time frame: First trimester (Between 9-9+6 days of gestational age)
Fetal growth
Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.
Time frame: First trimester (Between 11-11+6 days of gestational age)
Fetal growth
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.
Time frame: Second trimester (Between AD 22-25 weeks of gestational age)
Fetal growth
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.
Time frame: Third trimester (Between 30-33 weeks of gestational age)
Histological placental function
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
Time frame: Postpartum (<2 days postpartum)
Placental weight
Placental weight measured (in grams), weighed on the scale.
Time frame: Postpartum (<2 days postpartum)
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Jul 2022 (actual). Primary completion is estimated for Aug 2025, 37 months after the start.
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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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