Cologne Placenta Cohort (CPC)

• Conditions: Obesity, Maternal; Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: no intervention

• Registration Number: NCT05424965
• Lead Sponsor: Sarah Appel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-23
• Primary Completion: 2020-11-06
• Study First Submitted: 2022-01-04
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-17
• Last Update Submitted: 2022-06-17
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 247

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obese without gestational diabetes	no intervention	BMI \>= 30; normal glucose tolerance
normal weight with gestational diabetes	no intervention	BMI \< 25; impaired oral glucose tolerance
overweight with gestational diabetes	no intervention	BMI 25 - 29.9; impaired glucose tolerance
overweight without gestational diabetes	no intervention	BMI 25 - 29.9; normal glucose tolerance
obese with gestational diabetes	no intervention	BMI \>= 30; impaired glucose tolerance
normal weight without gestational diabetes	no intervention	BMI \< 25; normal glucose tolerance

Primary Outcome Measures

Name	Time	Method
Activity of Wnt signaling pathway in placental tissue	through study completion, about 4 years in total	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 \[relative protein level of protein or interest/relative protein level of normalization protein\].

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, NRW, Germany