NCT03232294

Brief Summary

Abnormal fetal development such as macrosomia can cause some complications on both fetus and mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy examination that it can be obtained during an examination of a pregnant woman by ultrasound. Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and increase childbirth complications and operative birth. There are some studies scrutinizing the relationship between FAWT and diabetes in the literature. However there are few studies which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome regarding with macrosomia in the second trimester.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1 year

First QC Date

July 25, 2017

Last Update Submit

July 25, 2017

Conditions

Keywords

fetal macrosomiafetal abdominal wall thicknesssubcutaneous adipose tissue

Outcome Measures

Primary Outcomes (1)

  • The relationship between fetal abdominal wall thickness and macrosomia

    6 months

Study Arms (1)

the study group

A total of 96 women with low risk pregnancy coming to the clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study

You may qualify if:

  • A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study and performed 75 gr- oral glucose tolerance test (OGTT).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Macrosomia

Condition Hierarchy (Ancestors)

Diabetes, GestationalPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • YUSUF MADENDAG

    Kayseri Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 27, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

June 1, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07