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The aim of this work is the prediction of fetal macrosomia by measuring:
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:
Calculation of gestational age will be based on the last reliable menstrual period or ultrasound examination within the first trimester.
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.
Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.
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.
HbA1c levels will be measured for diabetes patients.
All the patients will be subjected to :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregnant women with gestational diabetes | case group | ||
| non diabetic pregnant women | control group |
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| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight) | The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more. | at birth |
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical Cordcross-sectional Area | 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. | 36-37 weeks of gestation |
| Prediction of Fetal Macrosomia by Measuring HbA1C in Participants |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Women With Gestational Diabetes | case group The investigation will be performed to pregnant women with gestational diabetes
|
| FG001 | Non Diabetic Pregnant Women | control group The investigation will be performed to non diabetic pregnant women:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women With Gestational Diabetes | case group The investigation will be performed to pregnant women with gestational diabetes
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Umbilical Cordcross-sectional Area | 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 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 | Posted | Mean | Standard Deviation | cm^2 | 36-37 weeks of gestation |
|
from gestational week 27 to birth
Adverse Events were assessed during ultrasound examination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregnant Women With Gestational Diabetes | case group The investigation will be performed to pregnant women with gestational diabetes
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Rehab Mohamed Abdelrahman | Ain Shams University | +201004992772 | rehababdulrahman.rm@gmail.com |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique. |
| 36-37 weeks of gestation |
| Interventricular Septum Thickness | The interventricular septum thickness will be measured by ultrasound examination | 36-37 weeks of gestation |
| BG001 | Non Diabetic Pregnant Women | control group The investigation will be performed to non diabetic pregnant women:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Umbilical Cord Cross-sectional area | 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 at 27-28 weeks of gestation. | Mean | Standard Deviation | cm^2 |
|
| OG001 | Non Diabetic Pregnant Women | control group The investigation will be performed to non diabetic pregnant women:
|
|
|
| Secondary | Prediction of Fetal Macrosomia by Measuring HbA1C in Participants | Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique. | 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 | Posted | Mean | Standard Deviation | percentage of glycosolated hemoglobin | 36-37 weeks of gestation |
|
|
|
| Secondary | Interventricular Septum Thickness | The interventricular septum thickness will be measured by ultrasound examination | 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. | Posted | Mean | Standard Deviation | mm | 36-37 weeks of gestation |
|
|
|
| Primary | The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight) | The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more. | 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. | Posted | Number | participants | at birth |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Non Diabetic Pregnant Women | control group The investigation will be performed to non diabetic pregnant women:
| 0 | 40 | 0 | 40 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |