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Healthy Pregnant WomenPregWinNCT06925815

Pregnancy Cohort Study: Pregnancy as a Window to Future Health

An observational study of Healthy Pregnant Women and Obese Pregnant Women, run by Medical University of Graz at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational cohort study is to gain deep insights into how metabolic disorders such as obesity or diabetes during pregnancy affect the metabolic and cardiovascular health of mother and child in the short and long term. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
How many people
800 participants
Where
1 siteAustria
Study dates
27 Jul 2023to Jun 2034
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Eligible for participation are women with child wish and women with an on-going pregnancy who are planning to give birth at the university hospital in Graz, Austria. Women will be recruited as soon as possible in their pregnancy, but not after the 14th week of gestation. They will be recruited through the outpatient clinics and, in case of women with child wish, at the center for assisted reproductive technologies at the Department of Obstetrics and Gynecology, at Medical University Graz.

Who may be able to join

  • ongoing pregnancy prior to 14th gestational week, women with child wish; above 18 years of age, giving informed consent

Who cannot join

  • gestational age > 14th week of gestation; below 18 years of age; fetal genetic anomalies /malformation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christina Stern, Dr. med. contact

+43 316 385 86306

christina.stern@medunigraz.at

Austria1 site, 1 recruiting
  • Department of Obstetrics and Gynecology, Medical University of Graz

    Graz, Styria, 8036

    Evelyn Jantscher-Krenn, PhD, +43 316 385 80076, evelyn.jantscher-krenn@medunigraz.at

    Recruiting

Other trials in Austria

About this study

The goal of this observational cohort study is to gain deep insights into how metabolic disorders such as obesity or diabetes during pregnancy affect the metabolic and cardiovascular health of mother and child in the short and long term.

It will investigate the following questions:

  • How do maternal metabolic disorders affect pregnancy outcomes?
  • How do maternal metabolic disorders affect fetal growth?
  • How do maternal metabolic disorders affect the newborn's metabolism and body composition?
  • How do maternal metabolic disorders during pregnancy affect breast milk composition?
  • How do maternal metabolic disorders during pregnancy affect the metabolic health of the mother after birth? Participants in this study are pregnant women who will be asked to come to the clinics for three visits during their pregnancy, as well as for the delivery of their baby, and one time 2-3 months thereafter. At each visit, researchers will perform physical examinations (such as body composition measurements) and collect biological samples (blood, urine, saliva), clinical information, and lifestyle data. At birth, researchers will collect cord blood and breast milk as well as clinical data of the delivery and the health of the baby. Researchers will measure body fat in newborn babies and at 2-3 months of age.
Read the detailed description

Pregnancy is a sensitive and determining period in life where maternal and environmental cues can influence mother and offspring health short and long term. Negative exposures in pregnancy can have long term consequences, such as higher risk for development or aggravation of obesity, metabolic and cardiovascular diseases. However, preventive measures such as life style interventions can be particularly effective (window of opportunity) and could mitigate disease trajectories.

During a healthy pregnancy, a multitude of fine-tuned physiological adaptations takes place to meet the demands of the developing fetus and prepare maternal organism for delivery and lactation. These physiological changes affect the maternal metabolism, cardiovascular system, immune system, microbiome, or endocrine system. Unfavorable or adverse maternal factors (e.g. endocrine, genetic, metabolic, lifestyle factors) may compromise these adaptations, promoting pregnancy complications such as gestational diabetes (GDM), hypertensive pregnancy diseases, fetal growth restriction, fetal overgrowth, or preterm birth. These pregnancy pathologies not only pose an immediate health risk to both mother and child, but also may negatively impact the longer-term cardiovascular, endocrine, and metabolic health of both.

Offspring exposed in utero to maternal diabetes, hypertensive diseases or maternal obesity are at higher risk of developing obesity, diabetes of cardiovascular disorders later in life. For the mother, each pregnancy loads a metabolic burden, which is aggravated by pregnancy complications, also increasing the mother's risk of developing metabolic or cardiovascular disease later in life.

Therefore, prediction and risk evaluation, early diagnosis and prognosis, safe (non-invasive) therapeutic strategies are urgently needed to provide intervention as early as possible (pre-conceptional, during pregnancy and postpartum) to avoid potential manifestations of long-term health problems. Due to the relatively short duration of pregnancy and the often increased health awareness of expectant mothers, pregnancy is an ideal phase to identify origins of disease, evaluate personalized diagnostic and predictive markers, as well as preventive strategies.

In the recent years, the concept of deep phenotyping during pregnancy has emerged as a means to tackle the current inadequate understanding on the pathobiology of pregnancy related diseases and heath trajectories.

The proposed pregnancy and birth cohort aims to meet this need providing comprehensive sets of biological samples, clinical data, physical measurements and life style information for deep phenotyping of pregnancy and early life. Special focus will be put on monitoring glucose metabolism throughout pregnancy and postpartum, since the standard care oGTT at 24 to 28 weeks merely detects an already manifest glucose intolerance without giving any information on potentially preconceptionally existing impaired glucose tolerance/pre-diabetes or predicting maternal hyperglycemia thereafter, in late pregnancy.

This study will be a monocentric, prospective cohort with the goal of recruiting 80-100 participants per year. The study will be conducted at the LKH Graz University Hospital, Department of Gynecology and Obstetrics, Outpatient Clinic. Women with child wish will be recruited at the Center for Assisted Reproductive Technologies (Center for Gynecologic Endocrinology and Reproductive Medicine, Kinderwunsch-Zentrum) or pregnant women attending their routine first trimester screening visits will be enrolled and followed throughout their pregnancy until 8-12 weeks postpartum. There will be up to 6 visits: (T0 preconceptional enrollment), T1 (10-14 weeks of gestation, first trimester screening/enrollment), T2 (24-28 weeks of gestation, time of routine care oGTT); T3 (34-37 weeks of gestation, late pregnancy control visit in preparation for delivery), T4 (delivery), T5 (8-12 weeks postpartum; follow-up after pregnancy complications). The study is designed to closely monitor glucose metabolism and requires participants to be fasting for blood sampling. Women will be offered an oGTT at each visit (at T2 standard of care), but may opt out.

The study will collect clinical markers and measurements of metabolic and hemodynamic parameters, as well as a comprehensive collection of biospecimens and metadata on lifestyle factors (nutrition, physical activity). Advanced methods such as maternal and infant air displacement plethysmography (BODPOD /PEAPOD) will provide accurate body composition measurements. Endothelial/vascular function is assessed by hemodynamic parameters, including pulse wave velocity measured with a Vicorder®.

Keywords
pregnancy, deep phenotyping, maternal metabolism, body composition, longitudinal pregnancy cohort study, fetal growth, obesity in pregnancy, neonatal adiposity, gestational weight gain, gestational diabetes, cardiovascular health
Medical subject headings
Diabetes, Gestational, Pregnancy in Obesity, Gestational Weight Gain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal adiposity

    Measured as fat mass and fat-free mass by air displacement plethysmography (via BODPOD) at 10-14 weeks, 20-24 weeks and 34-37 weeks of gestation and 8-12 weeks post partum.

    Measured: From enrolment to 8-12 weeks post partum

  2. Maternal fasting blood glucose

    Fasting blood glucose as measured in mg/mL from NaF blood tubes at 10-14 weeks, 24-24 weeks, 34-37 weeks of gestation and 8-12 postpartum.

    Measured: from enrollment to 8-12 weeks postpartum

  3. Maternal blood pressure

    Blood pressure will be measured at 10-14 weeks, 24-28 weeks and 34-37 weeks of gestation and 8-12 weeks post partum.

    Measured: From enrolment to 8-12 weeks postpartum

  4. Maternal lipid profiles - triglycerides

    Analysis of serum lipid profiles: triglycerides at 3 time points during pregnancy (10-14 weeks (wks); 24-28wks; 34-37wks), and 8-12 wks postpartum.

    Measured: From enrolment to 8-12 weeks post partum

  5. Maternal lipid profiles: phospholipids

    Analysis of serum lipid profiles: phospholipids at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

    Measured: From enrolment to 8-12 weeks post partum

  6. Maternal lipid profiles: free fatty acids

    Analysis of serum lipid profiles: free fatty acids at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

    Measured: From enrolment to 8-12 weeks post partum

  7. Maternal lipid profiles: total cholesterol

    Analysis of serum lipid profiles: total cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

    Measured: From enrolment to 8-12 weeks post partum

  8. Maternal lipid profiles: HDL cholesterol

    Analysis of serum lipid profiles: HDL cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

    Measured: From enrolment to 8-12 weeks post partum

  9. Maternal lipid profiles: LDL cholesterol

    Analysis of serum lipid profiles: LDL cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.

    Measured: From enrolment to 8-12 weeks post partum

  10. Maternal endothelial function

    measured as pulse wave velocity using a Vicorder®.

    Measured: From enrolment to 8-12 weeks post partum

  11. Maternal cytokine profile

    Serum cytokines will be analysed by multiplexing at all visits during pregnancy and postpartum.

    Measured: From enrolment to 8-12 weeks postpartum

  12. Gestational diabetes

    assessed through 75g 2h oral glucose tolerance test performed at 24-28 weeks of gestation.

    Measured: From enrolment to child birth; 6 months

  13. Hypertensive disorders of pregnancy

    gestational hypertension and preeclampsia, assessed through medical chart review.

    Measured: From enrolment to child birth; 6 months

  14. Neonatal body composition at birth

    Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)

    Measured: between delivery and 48h postpartum

  15. Neonatal C-peptide in cord blood

    Concentrations of C-peptide in cord blood

    Measured: at birth

  16. Neonatal cytokine profile

    Neonatal inflammatory cytokines will be measured in cord blood serum collected at birth using multiplexing cytokine assays.

    Measured: at birth

  17. Neonatal epigenetic profile

    Epigenomic profile of the umbilical cord blood measured by DNA methylation

    Measured: at birth

Secondary outcomes (5)
  1. Human milk oligosaccharide (HMO) profile in maternal blood

    HMOs will be analysed in maternal serum by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: From enrolment to 8-12 weeks postpartum

  2. Human milk oligosaccharide (HMO) profile in maternal urine

    HMOs will be analysed in maternal serum by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: From enrolment to 8-12 weeks post partum

  3. Human milk oligosaccharide (HMO) profile in cord blood

    HMOs will be analysed in umbilical cord blood serum by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: at birth

  4. Human milk oligosaccharide (HMO) profile in breast milk

    HMOs will be analysed in breast milk by high pressure liquid chromatography (HPLC) with fluorescence detection

    Measured: from child birth to 8-12 weeks postpartum

  5. Adverse pregnancy outcome

    Composite measure including gestational hypertension, preeclampsia, gestational diabetes, preterm delivery, low birth weight, assessed through medical chart review

    Measured: From enrolment to child birth; 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start27 Jul 2023
  3. Primary completionJun 2033 (estimated)
  4. Study completionJun 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06925815
Sponsor's protocol ID
34-264 ex 21/22
Acronym
PregWin
Status last verified
Apr 2025
First submitted
7 Apr 2025
Last updated
13 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD underlying results in a publication will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Pregnant Women and Obese Pregnant Women, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evelyn Jantscher-Krenn, PhD (+43 316 385 80076, evelyn.jantscher-krenn@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal adiposity (time frame: From enrolment to 8-12 weeks post partum). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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