Trial Outcomes & Findings for The Role of Umbilical Cord Thickness in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus (NCT NCT02643225)
NCT ID: NCT02643225
Last Updated: 2016-08-18
Results Overview
The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
Recruitment status
COMPLETED
Target enrollment
80 participants
Primary outcome timeframe
at birth
Results posted on
2016-08-18
Participant Flow
Participant milestones
| Measure |
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 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.
|
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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Umbilical Cord Thickness in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Pregnant Women With Gestational Diabetes
n=40 Participants
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.
|
Non Diabetic Pregnant Women
n=40 Participants
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.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 7 • n=99 Participants
|
32 years
STANDARD_DEVIATION 7 • n=107 Participants
|
32 years
STANDARD_DEVIATION 7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Egypt
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Umbilical Cord Cross-sectional area
|
2.77 cm^2
STANDARD_DEVIATION 1.19 • n=99 Participants
|
2.06 cm^2
STANDARD_DEVIATION .77 • n=107 Participants
|
2.42 cm^2
STANDARD_DEVIATION .98 • n=206 Participants
|
PRIMARY outcome
Timeframe: at birthPopulation: 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.
The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.
Outcome measures
| Measure |
Pregnant Women With Gestational Diabetes
n=40 Participants
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.
|
Non Diabetic Pregnant Women
n=40 Participants
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.
|
|---|---|---|
|
The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)
|
17 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 36-37 weeks of gestationPopulation: 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
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.
Outcome measures
| Measure |
Pregnant Women With Gestational Diabetes
n=40 Participants
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.
|
Non Diabetic Pregnant Women
n=40 Participants
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.
|
|---|---|---|
|
Umbilical Cordcross-sectional Area
|
3.03 cm^2
Standard Deviation 1.26
|
2.25 cm^2
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: 36-37 weeks of gestationPopulation: 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
Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique.
Outcome measures
| Measure |
Pregnant Women With Gestational Diabetes
n=40 Participants
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.
|
Non Diabetic Pregnant Women
n=40 Participants
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.
|
|---|---|---|
|
Prediction of Fetal Macrosomia by Measuring HbA1C in Participants
|
6.6 percentage of glycosolated hemoglobin
Standard Deviation 1
|
5.2 percentage of glycosolated hemoglobin
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 36-37 weeks of gestationPopulation: 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.
The interventricular septum thickness will be measured by ultrasound examination
Outcome measures
| Measure |
Pregnant Women With Gestational Diabetes
n=40 Participants
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.
|
Non Diabetic Pregnant Women
n=40 Participants
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.
|
|---|---|---|
|
Interventricular Septum Thickness
|
0.85 mm
Standard Deviation 0.29
|
0.53 mm
Standard Deviation 0.12
|
Adverse Events
Pregnant Women With Gestational Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non Diabetic Pregnant Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place