Study of Placental Inflammation in Gestational Diabetes

NCT ID: NCT06884696

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2025-06-30

Brief Summary

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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

Detailed Description

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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

Conditions

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Gestational Diabetes Mellitus (GDM)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Women with gestational diabetes mellitus

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

Group Type EXPERIMENTAL

Blood samples for inflammatory markers

Intervention Type OTHER

Blood sampling

Placental Extract

Intervention Type OTHER

Placental sampling after caesarean section

Healthy women with uncomplicated pregnancy

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

Group Type EXPERIMENTAL

Blood samples for inflammatory markers

Intervention Type OTHER

Blood sampling

Placental Extract

Intervention Type OTHER

Placental sampling after caesarean section

Interventions

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Blood samples for inflammatory markers

Blood sampling

Intervention Type OTHER

Placental Extract

Placental sampling after caesarean section

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chiara Tersigni

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

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Fondazione Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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4978

Identifier Type: -

Identifier Source: org_study_id

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