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

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05835700

Collaborator

(none)

327

Enrollment

Location

Arms

Actual Duration (Months)

27.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gasdermin D Levels in Preterm Labor	Other: Gasdermin-d	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

327 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 15, 2021

Actual Primary Completion Date :

Jul 15, 2022

Actual Study Completion Date :

Jul 15, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nefise Nazlı YENIGUL	Bursa		Turkey	16110

Sponsors and Collaborators

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecology, Sanliurfa Mehmet Akif Inan Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT05835700

Other Study ID Numbers:

2011-KAEK-25 2021/06-11

First Posted:

Apr 28, 2023

Last Update Posted:

Apr 28, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecology, Sanliurfa Mehmet Akif Inan Education and Research Hospital

gasdermin D

preterm labor

pyroptosis

Additional relevant MeSH terms:

Premature Birth

Obstetric Labor, Premature

Study Results

No Results Posted as of Apr 28, 2023