Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes
NCT07336914
Diabetes Mellitus, Diabetes, Gestational
Peshawar, Khyber Pakhtunkhwa, Pakistan
View Trial DetailsNCT Number: NCT02643225
The aim of this work is the prediction of fetal macrosomia by measuring:
1. HbA1C. 2. Umbilical cord thickness. 3. Interventricular septum thickness.
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Notify Me20 year–35 year
Female
Observational
This prospective case control study will be carried out at Ain shams university maternity hospital between April 2015 and October 2015 on 80 patients. The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee. A verbal consent will be taken from each patient.
The following investigation will be performed:
The ultrasound examination will be with Voluson E6 equipped with a 3.5 Hz trans-abdominal probe at fetal medicine unit of maternity hospital Ain Shams University.
During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock's formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.
The cross sectional area of Wharton's jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.
All the patients will be subjected to :
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at birth
The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
Time frame: 36-37 weeks of gestation
the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.
Time frame: 36-37 weeks of gestation
Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique.
Time frame: 36-37 weeks of gestation
The interventricular septum thickness will be measured by ultrasound examination
Ain Shams University
Other
The Role of Umbilical Cord Thickness, Interventricular Septum Thickness and HbA1C Levels in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus
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