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

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ClinicalTrials.gov Identifier: NCT04421183
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Suleyman Guven, Karadeniz Technical University

Brief Summary:
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.

Condition or disease Intervention/treatment
Muc3 Pregnancy Induced Hypertension Diagnostic Test: draw blood

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Investigation of the Serum MUC3 Protein Levels in Gestational Hypertensive Disease (Preeclampsia-Eclampsia, Pregnancy Induced Hypertension, and HELLP Syndrome) Compared With Normal Pregnancy
Actual Study Start Date : June 1, 2010
Actual Primary Completion Date : January 1, 2011
Actual Study Completion Date : January 2, 2011


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnancy is female-specific. therefore, women were included in the study.
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421183


Locations
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Turkey
Karadeniz Technique University
Trabzon, Ortahisar, Turkey, 61080
Sponsors and Collaborators
Karadeniz Technical University
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Responsible Party: Suleyman Guven, professor, Karadeniz Technical University
ClinicalTrials.gov Identifier: NCT04421183    
Other Study ID Numbers: MUC 3
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suleyman Guven, Karadeniz Technical University:
Muc3
Preeclampsia
Eclampsia
HELLP
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications