Female Obesity Cohort and Intervention Study Group (MOCART Study Group)

NCT04924738 | Unknown

• 2 other identifiers: 102/19525/17
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational trial includes women with high risk pregnancies complicated with hyperglycemia in pregnancy and excessive body weight. The participants are enrolled when pregnant and monitored throughout pregnancy and delivery until the offspring is 6 months old. This research addresses the question which risk factors for non-communicable disorders such as hypertension, obesity, type 2 diabetes for a woman and her offspring can be detected during pregnancy and in early childhood.

Conditions

Obesity; Endocrine; Pregnancy in Diabetic; Child Obesity; Hypertension in Pregnancy

Keywords

DOHaD - developmental origins of health and disease; hyperglycemia in pregnancy; gestational weight gain; adipokines; endothelium dysfunction; large for gestational age; macrosomia; early life origins of health and disease

Outcome Measures

Primary Outcomes (3)

• maternal weight before delivery

  kg

  measured at term, within a week before delivery

• maternal weight in the early pregnancy

  kg

  measured after a viable pregnancy confirmed until a gestational age of 12 weeks

• birth weight

  g

  neonate's weight measured immediately after birth

Secondary Outcomes (4)

• maternal blood pressure at the term

  measured at term, within a week before delivery

• average maternal fasting glucose at the term

  measured seven times within two weeks before delivery

• average maternal postprandial glucose at the term

  measured one hour after main meals, twenty-one times within two weeks before delivery

• maternal HbA1c at the term

  glycated haemoglobin measured within a month before delivery

Study Arms (1)

MOZART_SG

Women treated for hyperglycemia in pregnancy. Observational data are to be collected at follow-up visits during pregnancy, at delivery and postpartum.

Behavioral: Monitoring and lifestyle

Interventions

Monitoring and lifestyle BEHAVIORAL

Dietary and lifestyle modification recommended for pregnant women with hyperglycemia detected in pregnancy.

MOZART_SG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Tertiary level of perinatal care unit.

You may qualify if:

• a woman in a singleton pregnancy referred to the Department of Reproduction, Poznan University of Medical Sciences
• maternal BMI (body mass index): 27 kg/m2 or above
• hyperglycemia detected in pregnancy according to the Polish Diabetes Association criteria, 2017
• delivery in the University Hospital

You may not qualify if:

• fetal malformation
• any serious maternal conditions that might hamper patient's participation in the tiral

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Department of Reproduction, Poznan University of Medical Sciences

Poznan, 60-535, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, serum, hair, cord blood

MeSH Terms

Conditions

Obesity; Pregnancy in Diabetics; Pediatric Obesity; Hypertension, Pregnancy-Induced; Disease; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Weight Gain; Body Weight Changes

Study Officials

• Ewa Wender-Ożegowska, prof.

  Head of the Department of Reproduction

  STUDY DIRECTOR

Central Study Contacts

Ewa Wender-Ożegowska, prof.

CONTACT

+4861859302; klinrozrod.gpsk.um@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: December 3, 2017
• Primary Completion: November 1, 2023
• Study Completion: August 1, 2024
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

PL (1)