Study of Placental Inflammation in Gestational Diabetes | NCT06884696

Studies
Study of Placental Inflammation in Gestational Diabetes

NCT06884696

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Mar 19, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Gestational Diabetes Mellitus (GDM)

Interventions

Blood samples for inflammatory markers
Placental Extract

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Mar 5, 2025

First Submission Date that Met QC Criteria

Mar 18, 2025

First Posted Date

Mar 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with gestational diabetes mellitus	Experimental	Blood and placenta sampling will be obtained from cases= women with gestational diabetes mellitus	Other: Blood samples for inflammatory markers Other: Placental Extract
Healthy women with uncomplicated pregnancy	Experimental	Blood and placenta sampling will be obtained from controls= women with uncomplicated pregnancy	Other: Blood samples for inflammatory markers Other: Placental Extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples for inflammatory markers	Other	Blood sampling	Healthy women with uncomplicated pregnancy Women with gestational diabetes mellitus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Placental inflammation	Analysis of protein expression of inflammasome NLRP3 and D6 scavenger receptor in placental tissue.	At delivery/birth

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chiara Tersigni	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Agostino Gemelli		Rome		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection
D010924	Placental Extracts

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided