The Relationship Between Serum Gasdermin-D Levels and Pyroptosis and Preterm Labor

April 18, 2023 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital

Research of the Relationship Between Serum Gasdermin-d Levels and Pyroptosis and Preterm Labor

In this study, the investigators aimed to investigate the relationship between Gasdermin D levels measured from the maternal serum of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective case- control study was conducted between 15 July 2021 and 15 July 2022 at Bursa Yüksek İhtisas Training and Research Hospital. The study was conducted with pregnant women between the ages of 18-45 who were idiopathic preterm labor. Pregnant women between the ages of 18-45 who were diagnosed with preterm labor between 24-37 weeks of gestational were included. This study was conducted with 160 pregnant women who were diagnosed with idiopathic preterm labor and 167 healthy pregnant women who were in the same gestational week as these pregnant women and were not diagnosed with preterm labor. Group 1 patients diagnosed with preterm labor between 24-37 weeks( study group) (n:160), Group 2 consisted of healthy pregnant women who were not diagnosed with preterm labor between 24-37 weeks ( control group) (n: 167) . In group 1, 80 patients were diagnosed with early preterm (between 24-34 weeks ) and 80 patients with late preterm labor (34-36+6 weeks).

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16110
        • Nefise Nazlı YENIGUL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women who were diagnosed with idiopathic preterm labor and gave birth in our hospital
  • Pregnant women without vaginal infection
  • Healthy pregnant women between 24-37 weeks without a diagnosis of preterm labor

Exclusion Criteria:

  • Multiple pregnancies
  • Pregnant women with a prediagnosis of chromosomal and congenital anomalies in the fetus
  • Women with a known infective or autoimmune disease before pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Gasdermin-D levels in preterm labor (study group)
Maternal serum Gasdermin-D levels of pregnant women who were diagnosed with idiopathic preterm labor
Other: Gasdermin-d
Maternal serum Gasdermin-D levels in preterm labor and healthy pregnant women.
Other: Gasdermin-D levels in healthy pregnant women (control group)
Maternal serum Gasdermin-D levels of healthy pregnant women
Other: Gasdermin-d
Maternal serum Gasdermin-D levels in preterm labor and healthy pregnant women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relationship between Gasdermin-D levels in preterm labor
Time Frame: 12 months
the relationship between Gasdermin-D levels of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2021/06-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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