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Active, not recruitingNCT06884696Updated Mar 19, 2025

Study of Placental Inflammation in Gestational Diabetes

An interventional study of Blood samples for inflammatory markers and Placental Extract in Gestational Diabetes Mellitus (GDM), sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jul 2022, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Gestational Diabetes Mellitus (GDM)
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 40 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
  • Infections (HIV,HCV)
  • Multiple pregnancy
  • Cancer
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Women with gestational diabetes mellitus

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

    Other: Blood samples for inflammatory markers · Other: Placental Extract

  • Experimental
    Healthy women with uncomplicated pregnancy

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

    Other: Blood samples for inflammatory markers · Other: Placental Extract

Interventions

  • OtherBlood samples for inflammatory markers

    Blood sampling

  • OtherPlacental Extract

    Placental sampling after caesarean section

06

What researchers measure

Primary outcomes

  1. Placental inflammation

    Analysis of protein expression of inflammasome NLRP3 and D6 scavenger receptor in placental tissue.

    Time frame: At delivery/birth

07

Study locations

1 site
  • Fondazione Policlinico Universitario Agostino Gemelli
    Rome, 00168, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06884696
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Mar 19, 2025
Start date
Jul 1, 2022
Primary completion
Jun 30, 2023
Completion
Jun 30, 2025 (estimated)
Last update
Mar 19, 2025

Study contacts

Chiara Tersigni
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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