- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421183
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
Ortahisar
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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
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 |
Intervention / Treatment |
---|---|
1
preeclampsia
|
draw blood from the all of patients
|
4
normal pregnancy without complication
|
draw blood from the all of patients
|
2
hellp
|
draw blood from the all of patients
|
3
eclampsia
|
draw blood from the all of patients
|
What is the study measuring?
Primary Outcome Measures
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
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)
June 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 2, 2011
Study Registration Dates
First Submitted
June 2, 2020
First Submitted That Met QC Criteria
June 4, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 4, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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