Gestational Diabetes
Conditions
Brief summary
The aim of this work is the prediction of fetal macrosomia by measuring: 1. HbA1C. 2. Umbilical cord thickness. 3. Interventricular septum thickness.
Detailed description
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: 1. 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. 2. 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. 3. HbA1c levels will be measured for diabetes patients. All the patients will be subjected to : 1. Full history taking including last menstrual period, medical history and past obstetric history. 2. Detailed general physical history examination and obstetrics examination. 3. Ultrasound examination in fetal medicine unit maternity hospital Ain shams university. 4. Venous blood samples will be taken from patients with gestational diabetes mellitus in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique. The patients will be followed up till delivery. The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
Interventions
None listed
Sponsors
Ain Shams University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Singleton gestation. 2. Gestational age over 27 weeks. 3. Intact membranes. 4. Normal umbilical morphology (two arteries and one vein). 5. Diagnosis of gestational diabetes.
Exclusion criteria
1. The presence of fetal congenital anomalies. 2. Multifetal pregnancy. 3. Maternal chronic diseases (hypertension, renal disease, cardiac and pulmonary disease, etc.). 4. Patients with a diagnosis such as oligohydramnios , pre-eclampsia and intrauterine growth retardation. 5. Patients who used cigarettes or alcohol during pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight) | at birth | The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical Cordcross-sectional Area | 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. |
| Prediction of Fetal Macrosomia by Measuring HbA1C in Participants | 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. |
| Interventricular Septum Thickness | 36-37 weeks of gestation | The interventricular septum thickness will be measured by ultrasound examination |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women With Gestational Diabetes case group The investigation will be performed to pregnant women with gestational diabetes
1. Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
2. Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, 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 and the interventricular septum thickness will be measured.
3. HbA1c levels will be measured for participants. | 40 |
| Non Diabetic Pregnant Women control group
The investigation will be performed to non diabetic pregnant women:
1. Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.
2. Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.
During ultrasound, 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 and the interventricular septum thickness will be measured.
3. HbA1c levels will be measured for participants. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Pregnant Women With Gestational Diabetes | Total | Non Diabetic Pregnant Women |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 80 Participants | 40 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 7 | 32 years STANDARD_DEVIATION 7 | 32 years STANDARD_DEVIATION 7 |
| Region of Enrollment Egypt | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Umbilical Cord Cross-sectional area | 2.77 cm^2 STANDARD_DEVIATION 1.19 | 2.42 cm^2 STANDARD_DEVIATION 0.98 | 2.06 cm^2 STANDARD_DEVIATION 0.77 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: at birth
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women With Gestational Diabetes | The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight) | 17 participants |
| Non Diabetic Pregnant Women | The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight) | 0 participants |
Secondary
Interventricular Septum Thickness
The interventricular septum thickness will be measured by ultrasound examination
Time frame: 36-37 weeks of gestation
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women With Gestational Diabetes | Interventricular Septum Thickness | 0.85 mm | Standard Deviation 0.29 |
| Non Diabetic Pregnant Women | Interventricular Septum Thickness | 0.53 mm | Standard Deviation 0.12 |
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.
Time frame: 36-37 weeks of gestation
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women With Gestational Diabetes | Prediction of Fetal Macrosomia by Measuring HbA1C in Participants | 6.6 percentage of glycosolated hemoglobin | Standard Deviation 1 |
| Non Diabetic Pregnant Women | Prediction of Fetal Macrosomia by Measuring HbA1C in Participants | 5.2 percentage of glycosolated hemoglobin | Standard Deviation 0.5 |
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.
Time frame: 36-37 weeks of gestation
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregnant Women With Gestational Diabetes | Umbilical Cordcross-sectional Area | 3.03 cm^2 | Standard Deviation 1.26 |
| Non Diabetic Pregnant Women | Umbilical Cordcross-sectional Area | 2.25 cm^2 | Standard Deviation 0.94 |