NCT03650790

Brief Summary

The complement C1q tumor necrosis factor-associated protein-9 (CTRP-9), which is responsible for regulating cardiovascular and metabolic functions, increases vascular relaxation by pathway dependent on AMPK / endothelial nitric oxide synthesis (eNOS). The aim of this study was to investigate CTRP-9 levels in pregnant women with preeclampsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

August 27, 2018

Last Update Submit

January 5, 2019

Conditions

Keywords

CTRPAdipocytokinespre-eclampsia

Outcome Measures

Primary Outcomes (1)

  • CTRP 9 level in preeclamptic pregnancies

    Blood samples were taken from patients with preeclampsia. The diagnosis was made when the arterial blood pressure was above 140/90 mm / Hg within 6 hours and was accompanied by proteinuria (\> 300 milligrams in a sample) with high blood pressure and number of patients with proteinuria (ACOG criteria)

    3 months

Study Arms (3)

preeclamptic obese pregnancy

ACTIVE COMPARATOR

CTRP 9 level will be assessed by 40 obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.

Diagnostic Test: Blood test

preeclamptic non-obese pregnancy

ACTIVE COMPARATOR

CTRP 9 level will be assessed by 40 non-obese preeclamptic gestational ELISA methods that meet the latest ACOG criteria.

Diagnostic Test: Blood test

normal pregnancy

ACTIVE COMPARATOR

CTRP 9 level will be assessed by 40 normal gestational ELISA methods

Diagnostic Test: Blood test

Interventions

Blood testDIAGNOSTIC_TEST

For serum analysis, approximately 2 cc antecubital vein venous blood serum will be taken from each patient to be studied for CTRP9 Level analysis. Adult blood will be centrifuged at 4000 rpm for 10 minutes to separate greenhouses. The obtained serum samples will be stored at -80 ° C until analysis.

normal pregnancypreeclamptic non-obese pregnancypreeclamptic obese pregnancy

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women who are ages 15-40
  • BMI ≥35 kg/m2 and BMI\<25 KG/m2 pregnants
  • The clinical diagnosis of preeclampsia will follow the current criteria outlined by ACOG 10
  • \> 20 th weeks of pregnancy

You may not qualify if:

  • A previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension,)
  • collagen vascular diseases,
  • inflammatory bowel disease
  • chronic inflammatory conditions,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diyarbakır Women's and Children's Hospital

Diyarbakır, 21100, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pre-EclampsiaObesity

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Şerif Aksin, specialist

    Diyarbakir Women's and Children's Diseases Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 40 obese preeclamptic pregnant women 40 non-obese preeclamptic pregnant women 40 normal pregnant women
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist doctor

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

September 3, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations