NCT04421183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2011

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

June 2, 2020

Last Update Submit

June 4, 2020

Conditions

Keywords

Muc3PreeclampsiaEclampsiaHELLP

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 month

Study Arms (4)

1

preeclampsia

Diagnostic Test: draw blood

4

normal pregnancy without complication

Diagnostic Test: draw blood

2

hellp

Diagnostic Test: draw blood

3

eclampsia

Diagnostic Test: draw blood

Interventions

draw bloodDIAGNOSTIC_TEST

draw blood from the all of patients

1234

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy is female-specific. therefore, women were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technique University

Trabzon, Ortahisar, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-EclampsiaEclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 9, 2020

Study Start

June 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 2, 2011

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations