Cologne Placenta Cohort (CPC)

NCT05424965 | Unknown

• 1 other identifier: 14-244
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study was to determine if signaling pathways in placentas of mothers affected by overweight/obesity or by gestational diabetes are altered compared to placentas of a control group (normal weight, no gestational diabetes). Moreover, maternal blood and umbilical cord blood were analysed.

Conditions

Obesity, Maternal; Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Activity of Wnt signaling pathway in placental tissue

  Analysis of components of the Wnt signaling pathway; like LRP6 receptor, beta-Catenin, GSK3beta, Wnt ligands (=proteins of interest) and an appropriate protein for normalization. Total protein lysates of placental tissue will be used. Analysis will be performed by western blotting and subsequent densitometric analysis. Outcome measure will be \[relative protein level of protein or interest/relative protein level of normalization protein\].

  through study completion, about 4 years in total

Study Arms (6)

normal weight without gestational diabetes

BMI \< 25; normal glucose tolerance

Other: no intervention

normal weight with gestational diabetes

BMI \< 25; impaired oral glucose tolerance

Other: no intervention

overweight without gestational diabetes

BMI 25 - 29.9; normal glucose tolerance

Other: no intervention

overweight with gestational diabetes

BMI 25 - 29.9; impaired glucose tolerance

Other: no intervention

obese without gestational diabetes

BMI \>= 30; normal glucose tolerance

Other: no intervention

obese with gestational diabetes

BMI \>= 30; impaired glucose tolerance

Other: no intervention

Interventions

no intervention OTHER

no intervention

normal weight with gestational diabetes; normal weight without gestational diabetes; obese with gestational diabetes; obese without gestational diabetes; overweight with gestational diabetes; overweight without gestational diabetes

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obstetrics deptartment of a University Hospital

You may qualify if:

• singleton pregnancy
• BMI before pregnancy \>= 18
• with \& without gestational diabetes
• c-section at gestational week 35+0 until 41+6

You may not qualify if:

• multiple pregnancy
• maternal serious internal disease
• infections before pregnancy (e.g. HIV, hepatitis B)
• pregnancy-associates diseases (e.g. gestoses, androgen insensitivity syndrome)

Sponsors & Collaborators

• Sarah Appel: lead

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

placenta tissue, maternal blood (plasma, serum, EDTA-blood), umbilical cord blood (plasma, EDTA-blood).

MeSH Terms

Conditions

Pregnancy in Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Appel, Dr.

  Universitätsklinikum Köln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: June 21, 2022
• Study Start: March 23, 2018
• Primary Completion: November 6, 2020
• Study Completion: December 31, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)