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

Not Applicable

Completed

• Conditions: Gasdermin D Levels in Preterm Labor
• Interventions: Other: Gasdermin-d

• Registration Number: NCT05835700
• Lead Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

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).

Study Timeline

• Study Start: 2021-07-15
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Status Verified: 2023-04
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Study First Posted: 2023-04-28
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 327

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gasdermin-D levels in healthy pregnant women (control group)	Gasdermin-d	Maternal serum Gasdermin-D levels of healthy pregnant women
Gasdermin-D levels in preterm labor (study group)	Gasdermin-d	Maternal serum Gasdermin-D levels of pregnant women who were diagnosed with idiopathic preterm labor

Primary Outcome Measures

Name	Time	Method
relationship between Gasdermin-D levels in preterm labor	12 months	the relationship between Gasdermin-D levels of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.

Trial Locations

Locations (1)

Nefise Nazlı YENIGUL; 🇹🇷 Bursa, Turkey