- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05924061
The Role of Pentraxin 3 and Cathepsin B Levels in Preeclamptic Pregnancy
June 19, 2023 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
The Role of Pentraxin 3 and Cathepsin B Levels in the Second Trimester in Predicting of Maternal and Fetal Results in Preeclamptic Pregnancy
In this study, the investigator aim was to compare Cathepsin B and Pentraxin 3 levels measured from maternal serum of pregnant women diagnosed with preeclampsia in the second trimester, the effects of these levels on maternal/ fetal outcomes and the composite results of Cathepsin B and Pentraxin 3 levels alone or together and contribute to the literature in this area.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This prospective case-control study was conducted between 1 January 2022 and 31 December 2022 at Bursa Yuksek Ihtisas Training and Research Hospital.
The study was conducted with pregnant women between ages of 18-45 who were diagnosed with preeclampsia in the second trimester.
This study was conducted with total 156 pregnant women.
participants were grouped according to the presence of preeclampsia; Group1: Patients diagnosed with preeclampsia between 20-28 weeks (study group) (n:78) , Group 2: Healthy pregnant women between 20-28 weeks without a diagnosis of preeclampsia ( control group) (n:78) .
As soon as preeclampsia is diagnosed and before any treatment was started, maternal serum samples were collected in the Cathepsin B and Pentraxin 3 kit in amounts suitable for the study.
The samples obtained were kept in biochemistry laboratory at -80 degrees until the study was conducted.
After all samples were collected, Cathepsin B and Pentraxin 3 values were measured by ELISA method.
Study Type
Observational
Enrollment (Actual)
156
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bursa, Turkey, 16110
- Nefise Nazlı YENIGUL
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
singleton pregnancy white people socio-cultural differences were not considered
Description
Inclusion Criteria:
- Singleton pregnancy
- Pregnant women diagnosed with preeclampsia between 20-28 weeks of gestation
- Healthy pregnant women between 20-28 weeks of gestation who want to be involved in the study.
Exclusion Criteria:
- Multiple pregnancies
- Pregnant women who gave birth below 24 weeks of gestation
- Pregnant women diagnosed with other hypertensive diseases of pregnancy other than preeclampsia ( gestational hypertension, chronic hypertension, superimposed hypertension)
- Pregnant women with chromosomal or congenital anomalies in the fetus
- Women with a known infective or autoimmune disease before pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant women with preeclampsia between 20-28 weeks (study group)
Maternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks pregnant women with preeclampsia
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The effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia
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Healthy pregnant women between 20-28 weeks ( control group)
Maternal serum cathepsin B and pentraxin 3 levels in 20-28 weeks healthy pregnant women ( control group)
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The effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the effects and composite results of cathepsin b and pentraxin 3 levels in pregnant women diagnosed with preeclampsia
Time Frame: 12 months
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serum cathepsin b (nmoL pNA/mL) and serum pentraxin 3 (ng/ml) levels composite results on pregnant women diagnosed with preeclampsia
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
April 4, 2023
First Submitted That Met QC Criteria
June 19, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 19, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-KAEK-25 2021/09-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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