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

Primary Purpose

Gasdermin D Levels in Preterm Labor

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Gasdermin-d

About this trial

This is an interventional other trial for Gasdermin D Levels in Preterm Labor focused on measuring gasdermin D, preterm labor, pyroptosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Nefise Nazlı YENIGUL

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Gasdermin-D levels in preterm labor (study group)

Gasdermin-D levels in healthy pregnant women (control group)

Arm Description

Maternal serum Gasdermin-D levels of pregnant women who were diagnosed with idiopathic preterm labor

Maternal serum Gasdermin-D levels of healthy pregnant women

Outcomes

Primary Outcome Measures

relationship between Gasdermin-D levels in preterm labor

the relationship between Gasdermin-D levels of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.

Secondary Outcome Measures

Full Information

NCT ID

NCT05835700

First Posted

April 4, 2023

Last Updated

April 18, 2023

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05835700

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

July 15, 2021 (Actual)

Primary Completion Date

July 15, 2022 (Actual)

Study Completion Date

July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gasdermin D Levels in Preterm Labor

Keywords

gasdermin D, preterm labor, pyroptosis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Gastermin D and Pentaxin 3 levels were measured in the patients participating in the study. These are not routinely checked markers. Participants were assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on preeclampsia or HELLP related outcomes. Due to this, our work is interventional.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

327 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gasdermin-D levels in preterm labor (study group)

Arm Type

Other

Arm Description

Maternal serum Gasdermin-D levels of pregnant women who were diagnosed with idiopathic preterm labor

Arm Title

Gasdermin-D levels in healthy pregnant women (control group)

Arm Type

Other

Arm Description

Maternal serum Gasdermin-D levels of healthy pregnant women

Intervention Type

Other

Intervention Name(s)

Gasdermin-d

Intervention Description

Maternal serum Gasdermin-D levels in preterm labor and healthy pregnant women.

Primary Outcome Measure Information:

Title

relationship between Gasdermin-D levels in preterm labor

Description

the relationship between Gasdermin-D levels of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.

Time Frame

12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Nefise Nazlı YENIGUL

City

Bursa

ZIP/Postal Code

16110

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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