NCT03808571

Brief Summary

: The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in pregnancies with intrauterine growth retardation and to determine whether they are associated with abnormal fetal doppler findings or not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 16, 2019

Last Update Submit

January 17, 2019

Conditions

Nesfatin-1IrisinIntrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • cord blood nesfatn-1 level measurement

    cord blood levels of nesfatin-1 in pregnancies with intrauterine growth restricted fetuses and healthy pregnancies.

    9 months

Secondary Outcomes (1)

  • Cord blood irisin level measurement

    9 months

Study Arms (2)

Study group

Pregnancies complicated with intrauterine growth restricted fetuses

Other: cord blood specimen during the delivery

Control group

Healthy pregnancies

Other: cord blood specimen during the delivery

Interventions

cord blood specimen during the deliveryOTHER

The cord blood will be taken during the delivery of baby.

Control groupStudy group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • Pregnant women with intrauterine grwoth rectricted fetuses.
  • Healthy pregnancies

You may not qualify if:

  • Pregnant women with chronic medical conditions
  • multiple pregnancies
  • fetuses with fetal malfomations or genetic syndromes
  • pregnant women older than 45 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology

Van, 65000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cord blood specimen

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate doctor

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 17, 2019

Study Start

January 1, 2018

Primary Completion

January 10, 2019

Study Completion

January 15, 2019

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations

TU(1)