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

NCT ID: NCT05835700

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

327 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2022-07-15

Brief Summary

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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

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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).

Conditions

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Gasdermin D Levels in Preterm Labor

Keywords

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gasdermin D preterm labor pyroptosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Gasdermin-D levels in preterm labor (study group)

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

Group Type OTHER

Gasdermin-d

Intervention Type OTHER

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

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

Maternal serum Gasdermin-D levels of healthy pregnant women

Group Type OTHER

Gasdermin-d

Intervention Type OTHER

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

Interventions

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Gasdermin-d

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanliurfa Mehmet Akif Inan Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nefise Nazlı YENIGUL

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nefise Nazlı YENIGUL

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011-KAEK-25 2021/06-11

Identifier Type: -

Identifier Source: org_study_id