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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

Tracking Information
First Submitted Date July 25, 2017
First Posted Date July 27, 2017
Last Update Posted Date July 27, 2017
Actual Study Start Date April 1, 2016
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2017)
The relationship between fetal abdominal wall thickness and macrosomia [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fetal Front-abdominal Wall Thickness and Perinatal Outcome
Official Title Effect of Fetal Front-abdominal Wall Thickness on Birth Weight and Perinatal Outcome at 24-26. Gestational Weeks
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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
Condition
  • Fetal Macrosomia
  • Abdominal Wall Mass
  • Perinatal Problems
Intervention Not Provided
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2017)
96
Original Actual Enrollment Same as current
Actual Study Completion Date June 1, 2017
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03232294
Other Study ID Numbers 2017/222
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Yusuf MADENDAG, Kayseri Education and Research Hospital
Study Sponsor Kayseri Education and Research Hospital
Collaborators Not Provided
Investigators
Principal Investigator: YUSUF MADENDAG Kayseri Education and Research Hospital
PRS Account Kayseri Education and Research Hospital
Verification Date July 2017