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Fetal Front-abdominal Wall Thickness and Perinatal Outcome

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ClinicalTrials.gov Identifier: NCT03232294
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Yusuf MADENDAG, Kayseri Education and Research Hospital

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.

Condition or disease
Fetal Macrosomia Abdominal Wall Mass Perinatal Problems

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Study Type : Observational [Patient Registry]
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Effect of Fetal Front-abdominal Wall Thickness on Birth Weight and Perinatal Outcome at 24-26. Gestational Weeks
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. The relationship between fetal abdominal wall thickness and macrosomia [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

The participants with a positive 75-g OGTT were excluded. Additionally those following criteria were accepted as the exclusion criteria of this study: hypertension, preeclampsia, diabetes, fetal distress, fetal anomaly, multiple pregnancy, preterm labor, preterm premature rupture of membrane, placenta previa, polyhydramnios and intrauterine fetal growth restriction.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232294


Sponsors and Collaborators
Kayseri Education and Research Hospital
Investigators
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Principal Investigator: YUSUF MADENDAG Kayseri Education and Research Hospital
Additional Information:

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Responsible Party: Yusuf MADENDAG, principal investigator, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03232294    
Other Study ID Numbers: 2017/222
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yusuf MADENDAG, Kayseri Education and Research Hospital:
fetal macrosomia
fetal abdominal wall thickness
subcutaneous adipose tissue
Additional relevant MeSH terms:
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Fetal Macrosomia
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight