Muc3MUC3NCT04421183
Investigation of the Serum Mucoprotein 3 (MUC3) Protein Levels in Gestational Hypertensive Disease
An observational study of Muc3 and Pregnancy Induced Hypertension, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muc3, Pregnancy Induced Hypertension
- What is being tested?
- draw blood
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2010to 2 Jan 2011
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and antiepileptic drugs
- smoking,history of cancer, multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technique University
Trabzon, Ortahisar, 61080
About this study
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
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.
Read the 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.
- Conditions
- Muc3, Pregnancy Induced Hypertension
- Being tested
- draw blood
- Keywords
- Muc3, Preeclampsia, Eclampsia, HELLP
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
draw bloodDiagnostic test
draw blood from the all of patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | preeclampsia Receives: Diagnostic Test: draw blood | |
| 4 | normal pregnancy without complication Receives: Diagnostic Test: draw blood | |
| 2 | hellp Receives: Diagnostic Test: draw blood | |
| 3 | eclampsia Receives: Diagnostic Test: draw blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Blood Samples
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.
Measured: 6 months
Measurement of Mucoprotein in Serum
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2010
- Primary completion1 Jan 2011
- Study completion2 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muc3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421183
- Sponsor's protocol ID
- MUC 3
- Acronym
- MUC3
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04421183
- Acronym / sponsor ID
- MUC3 / MUC 3
- Conditions
- Muc3, Pregnancy Induced Hypertension
- Keywords
- Muc3, Preeclampsia, Eclampsia, HELLP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 1 Jan 2011 (actual)
- Study completion
- 2 Jan 2011 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: draw bloodpreeclampsia |
| 4 | – | Diagnostic Test: draw bloodnormal pregnancy without complication |
| 2 | – | Diagnostic Test: draw bloodhellp |
| 3 | – | Diagnostic Test: draw bloodeclampsia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- using antihypertensive, anticoagulant, NSAID, corticosteroid or antiplatelet and antiepileptic drugs
- smoking,history of cancer, multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| draw blooddraw blood from the all of patients | Diagnostic test | 1, 2, 3, 4 |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muc3 and Pregnancy Induced Hypertension, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Blood Samples (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.