Gasdermin D Levels in Preterm LaborNCT05835700
The Relationship Between Serum Gasdermin-D Levels and Pyroptosis and Preterm Labor
A study testing Gasdermin-d in people with Gasdermin D Levels in Preterm Labor, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gasdermin D Levels in Preterm Labor
- What is being tested?
- Gasdermin-d
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Gasdermin D Levels in Preterm Labor
- Being tested
- Gasdermin-d
- Keywords
- gasdermin D, preterm labor, pyroptosis
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gasdermin-dOther
Maternal serum Gasdermin-D levels in preterm labor and healthy pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Gasdermin-D levels in preterm labor (study group) | Other | Maternal serum Gasdermin-D levels of pregnant women who were diagnosed with idiopathic preterm labor Receives: Other: Gasdermin-d |
| Gasdermin-D levels in healthy pregnant women (control group) | Other | Maternal serum Gasdermin-D levels of healthy pregnant women Receives: Other: Gasdermin-d |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start15 Jul 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gasdermin D Levels in Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835700
- Sponsor's protocol ID
- 2011-KAEK-25 2021/06-11
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of the Relationship Between Serum Gasdermin-d Levels and Pyroptosis and Preterm Labor
- ClinicalTrials.gov ID
- NCT05835700
- Acronym / sponsor ID
- 2011-KAEK-25 2021/06-11
- Conditions
- Gasdermin D Levels in Preterm Labor
- Keywords
- gasdermin D, preterm labor, pyroptosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gasdermin-D levels in preterm labor (study group) | Other | Other: Gasdermin-dMaternal serum Gasdermin-D levels of pregnant women who were diagnosed with idiopathic preterm labor |
| Gasdermin-D levels in healthy pregnant women (control group) | Other | Other: Gasdermin-dMaternal serum Gasdermin-D levels of healthy pregnant women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gasdermin-dMaternal serum Gasdermin-D levels in preterm labor and healthy pregnant women. | Other | Gasdermin-D levels in healthy pregnant women (control group), Gasdermin-D levels in preterm labor (study group) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gasdermin-d in people with Gasdermin D Levels in Preterm Labor, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between Gasdermin-D levels in preterm labor (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.