Investigation of the Serum Mucoprotein 3 (MUC3) Protein Levels in Gestational Hypertensive Disease (MUC3)

June 4, 2020 updated by: Suleyman Guven, Karadeniz Technical University

Investigation of the Serum MUC3 Protein Levels in Gestational Hypertensive Disease (Preeclampsia-Eclampsia, Pregnancy Induced Hypertension, and HELLP Syndrome) Compared With Normal Pregnancy

Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20 gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010- January 2011.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypertensive diseases of pregnancy are one of the most frequently encountered reasons for maternal and neonatal morbidity and mortality. The excretion of high levels of mucoprotein takes part in the pathogenesis of preeclampsia through restraining trophoblast invasion. This study aimed to investigate levels of serum mucoprotein three in hypertensive diseases of pregnancy. This study included a total of eighty cases that 20 normal pregnancy, 20 gestational hypertension, 20 preeclampsia, and 20 HELLP syndrome patients from June 2010- January 2011. This is the first study measuring levels of serum mucoprotein three in gestational hypertensive disease. MUC3 levels showed a distinctive increase in hypertensive diseases of pregnancy compared with the pregnant control group. As a result, it is found that plasma mucoprotein 3 levels increase as the severity of hypertensive diseases of pregnancy increases; and plasma mucoprotein 3 could be a precursor for the evaluation of the severity of the disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

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

  • Turkey
    • Ortahisar
      • Trabzon, Ortahisar, Turkey, 61080
        • Karadeniz Technique University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients who were diagnosed with hypertensive disease among the patients who applied to the pregnant clinic of Karadeniz Technical University Faculty of Medicine, Obstetrics and Gynecology Department with the approval of the KTÜ Faculty of Medicine Research Ethics Committee dated 27.05.2010 and 154 number ( 80 cases, including the study group and 20 normotensive pregnant control group) were included in the study between June 2010 and January 2011.

Description

Inclusion Criteria:

  • To accept the consent to participate in the research and sign the form,
  • According to ACOG 2002, pregnancy meets the criteria of hypertensive diseases [1], The diagnosis of HELLP syndrome was made according to the criteria described by Sibai. These; abnormal peripheral smear, schistocyte in the peripheral smear, lactate dehydrogenase > 600 U / L, hemolysis, total bilirubin> 1.2 mg / dl, AST> 70 U / L, platelet count <100,000mm3.
  • When the demographic characteristics and CVs of all cases were questioned in the initial evaluation, not having chronic inflammation or acute infection, not having any systemic disease, recurrent pregnancy loss, thrombophilia, antiphospholipid antibody syndrome,
  • Not smoking, No history of cancer, No multiple pregnancies
  • Not using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and antiepileptic drugs

Exclusion Criteria:

  • using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and antiepileptic drugs
  • smoking,history of cancer, multiple pregnancies

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1
preeclampsia
Diagnostic test: draw blood
draw blood from the all of patients
4
normal pregnancy without complication
Diagnostic test: draw blood
draw blood from the all of patients
2
hellp
Diagnostic test: draw blood
draw blood from the all of patients
3
eclampsia
Diagnostic test: draw blood
draw blood from the all of patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Collection of Blood Samples
Time Frame: 6 months
The blood samples required for the study were obtained from samples taken into a heparinized tube. Maternal blood samples were taken at the time of diagnosis in patients with preeclamptic - eclamptic, gestational hypertension and HELLP syndrome before starting any treatment when they apply for delivery in normal pregnant women. After the blood samples were centrifuged at Eppendorf Centrifuge-5084R at 3000 G for 10 minutes, the serum was separated. Some of the serum collected were placed in a 1.5 cc Eppendorf tube and stored at -80 ˚C in the medical cooler (Ariston) in the Department of Obstetrics and Gynecology.
6 months
Measurement of Mucoprotein in Serum
Time Frame: 1 month
After collecting all serum samples (80 pieces), they were dissolved at room temperature and MUC3 (Human Mucin 3, MUC3 ELISA Kit) level was measured in serum samples with the help of commercial ELISA kits. The measurement technique principle is given below.Mucoprotein content in serum was determined in ng/ml with the help of a special ELISA kit system and elements for mucoprotein 3.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUC 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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