Study of Placental Inflammation in Gestational Diabetes

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Other: Blood samples for inflammatory markers; Other: Placental Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT06884696

4978

Details and patient eligibility

About

The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6

Full description

The aim of this study is to investigate systemic and placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6, compared to women with uncomplicated pregnancy

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with gestational diabetes mellitus
• Women with uncomplicated pregnancy
• Age >18 years
• Singleton pregnancy

Exclusion criteria

• Age < 18 years
• Infections (HIV,HCV)
• Multiple pregnancy
• Cancer

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Women with gestational diabetes mellitus

Experimental group

Description:

Blood and placenta sampling will be obtained from cases= women with gestational diabetes mellitus

Treatment:

Other: Placental Extract

Other: Blood samples for inflammatory markers

Healthy women with uncomplicated pregnancy

Experimental group

Description:

Blood and placenta sampling will be obtained from controls= women with uncomplicated pregnancy

Treatment:

Other: Placental Extract

Other: Blood samples for inflammatory markers