Pregnancy Cohort Study: Pregnancy as a Window to Future Health (PregWin)

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes; Obese Pregnant Women; Healthy Pregnant Women

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®.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Evelyn Jantscher-Krenn, PhD; Phone Number: +43 316 385 80076; Email: evelyn.jantscher-krenn@medunigraz.at
• Study Contact Backup: Name: Christina Stern, Dr. med.; Phone Number: +43 316 385 86306; Email: christina.stern@medunigraz.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Department of Obstetrics and Gynecology, Medical University of Graz
      • Contact: Evelyn Jantscher-Krenn, PhD; Phone Number: +43 316 385 80076; Email: evelyn.jantscher-krenn@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrolment to 8-12 weeks post partum
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.	from enrollment to 8-12 weeks postpartum
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.	From enrolment to 8-12 weeks postpartum
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.	From enrolment to 8-12 weeks post partum
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.	From enrolment to 8-12 weeks post partum
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.	From enrolment to 8-12 weeks post partum
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.	From enrolment to 8-12 weeks post partum
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.	From enrolment to 8-12 weeks post partum
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.	From enrolment to 8-12 weeks post partum
Maternal endothelial function	measured as pulse wave velocity using a Vicorder®.	From enrolment to 8-12 weeks post partum
Maternal cytokine profile	Serum cytokines will be analysed by multiplexing at all visits during pregnancy and postpartum.	From enrolment to 8-12 weeks postpartum
Gestational diabetes	assessed through 75g 2h oral glucose tolerance test performed at 24-28 weeks of gestation.	From enrolment to child birth; 6 months
Hypertensive disorders of pregnancy	gestational hypertension and preeclampsia, assessed through medical chart review.	From enrolment to child birth; 6 months
Neonatal body composition at birth	Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)	between delivery and 48h postpartum
Neonatal C-peptide in cord blood	Concentrations of C-peptide in cord blood	at birth
Neonatal cytokine profile	Neonatal inflammatory cytokines will be measured in cord blood serum collected at birth using multiplexing cytokine assays.	at birth
Neonatal epigenetic profile	Epigenomic profile of the umbilical cord blood measured by DNA methylation	at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human milk oligosaccharide (HMO) profile in maternal blood	HMOs will be analysed in maternal serum by high pressure liquid chromatography (HPLC) with fluorescence detection	From enrolment to 8-12 weeks postpartum
Human milk oligosaccharide (HMO) profile in maternal urine	HMOs will be analysed in maternal serum by high pressure liquid chromatography (HPLC) with fluorescence detection	From enrolment to 8-12 weeks post partum
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	at birth
Human milk oligosaccharide (HMO) profile in breast milk	HMOs will be analysed in breast milk by high pressure liquid chromatography (HPLC) with fluorescence detection	from child birth to 8-12 weeks postpartum
Adverse pregnancy outcome	Composite measure including gestational hypertension, preeclampsia, gestational diabetes, preterm delivery, low birth weight, assessed through medical chart review	From enrolment to child birth; 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal vaginal microbiome	From the extracted DNA, 16S rRNA genes will be amplified using specific primers for bacterial and archaeal communities. The amplicons obtained will be prepared for Illumina MiSeq Sequencing.	From enrolment to 8-12 weeks postpartum

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Evelyn Jantscher-Krenn, PhD, Medical University of Graz; Study Director: Herbert Fluhr, Univ.-Prof. Dr. med., Medical University of Graz; Principal Investigator: Christina Stern, Dr. med., Medical University of Graz; Principal Investigator: Ursula Hiden, Assoc. Prof., Medical University of Graz; Principal Investigator: Federica Piani, MD, PhD, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2023
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2034

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; body composition; gestational diabetes; gestational weight gain; cardiovascular health; fetal growth; neonatal adiposity; obesity in pregnancy; deep phenotyping; maternal metabolism; longitudinal pregnancy cohort study
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Overnutrition; Body Weight; Pregnancy Complications; Body Weight Changes; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Obesity; Weight Gain; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Gestational Weight Gain; Diabetes, Gestational; Pregnancy in Obesity
• Other Study ID Numbers: 34-264 ex 21/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD underlying results in a publication will be shared.
• IPD Sharing Time Frame: Data will be made available starting 1 year after publication with no end date.
• IPD Sharing Access Criteria: Data access will be provided to external researchers who submit a methodologically sound proposal for secondary data analysis that is approved by the study investigators and should be submitted to the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No