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

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

      • Bursa, Turkey, 16110
        • Nefise Nazlı YENIGUL

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
The effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia
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)
The effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia

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
serum cathepsin b (nmoL pNA/mL) and serum pentraxin 3 (ng/ml) levels composite results on pregnant women diagnosed with preeclampsia
12 months

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

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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