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To determine and evaluate the diagnostic performance of Doppler sonography of umbilical artery (UA), fetal middle cereberal artery (MCA), ductus venosus (VD) and umbilical vein (UV) for prediction of adverse perinatal outcome among diabetic pregnant women.
The included women age will range between 18 and 35 years old. They will be pregnant in a singleton healthy living fetus at a gestational age between 34 and 39 weeks (confirmed by a reliable date for the last menstrual period or/and 1st trimester ultrasound scan). Women with other maternal medical disorders that may affect perinatal outcome rather than diabetes will be excluded from the study. Exclusion criteria also include women with pre-labour rupture of membrane, antepartum hemorrhage, fetuses with congenital anomalies and those who will receive respiratory depressants (e.g., opioid analgesics) within 2 hours of delivery. According to NICE guidelines 2015[13], gestational diabetes is diagnosed if the woman has either:
Colour flow imaging will be used to display the circle of Willis. Then, calculation of the cerebro-placental ratio (CPR) will be done. Ductus venosus (DV) Doppler will be sampled soon after its origin from the umbilical vein. Also measurement of fetal umbilical vein (UV) flow will be done.
From the flow velocity waveforms of the UA and MCA, the pulsatility index (PI) & the resistance index (RI) will be measured. From the flow velocity waveforms of the DV, peak velocity index (PVIV), peak systolic velocity (PSV) and A wave will be measured.
From the umbilical vein flow, the presence or absence of pulsatile flow will be recorded.
All labours will be attended by an expert neonatologist who will be blinded to the results of Doppler indices measurements & the following will be recorded: APGAR score at (1 & 5 min) -Neonatal birth weight - Fetal growth restriction (FGR) will be defined as birth weight of less than 10 th percentile of newborn weight in normal pregnancies at corresponding gestational age - Fetal macrosomia will be defined as birth weight of more than 90th percentile of newborn weight in normal pregnancies at corresponding gestational age - The occurrence of respiratory complications [Transient Tachypnea of the newborn (TTN) or Respiratory Distress Syndrome (RDS)] - The occurrence of neonatal hypoglycemia was defined as blood glucose level less than 2 mmol/liter (35 mg/dL) - The further need for neonatal intensive care unit (NICU) admission and Perinatal death.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| good perinatal outcome | Fasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler |
| |
| poor perinatal outcome | Fasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study | Diagnostic Test | Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study |
|
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic value of umbilical artery (UA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients | The diagnostic value of umbilical artery (UA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among diabetic pregnant patients. Sensitivity and specificity of umbilical artery RI & PI in detecting adverse perinatal outcome. | within 24 hours before delivery |
| The diagnostic value of middle cerebral artery (MCA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients | The diagnostic value of middle cerebral artery (MCA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among diabetic pregnant patients. Sensitivity and specificity of middle cerebral artery RI & PI in detecting adverse perinatal outcome. | within 24 hours before delivery |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic value of cerebroplacental ratio (CPR) in predicting adverse perinatal outcome among diabetic pregnant patients. | The diagnostic value of cerebroplacental ratio (CPR) [MCA/UA PI] in predicting adverse perinatal outcome among diabetic pregnant patients. Sensitivity and specificity of CPR in detecting adverse perinatal outcome. | within 24 hours before delivery |
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Inclusion Criteria:
Exclusion Criteria:
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pregnant female
140 pregnant women, will be recruited from emergency and inpatients departments.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hany Saad, MD | Contact | 01001817211 | hanysaad25280@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hany Saad, MD | Kasr Alainy Hospital(Faculty of Medicine -Cairo university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D005320 | Fetal Macrosomia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D019518 | Postprandial Period |
| D015150 | Echocardiography, Doppler |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
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| The diagnostic value of ductus venosus Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients. | The diagnostic value of ductus venosus Doppler indices ( PVIV,PSV and abnormal A wave) in predicting adverse perinatal outcome among diabetic pregnant patients. Sensitivity and specificity of ductus venosus PVIV,PSV and abnormal A wave in detecting adverse perinatal outcome. | within 24 hours before delivery |
| Kasr Alainy hospital (Faculty of Medicine-Cairo University) | Recruiting | Cairo | 11956 | Egypt |
|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005315 | Fetal Diseases |
| D011254 | Pregnancy in Diabetics |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D048909 | Diabetes Complications |
| D001724 | Birth Weight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |