the Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome

NCT05410080 | Unknown

• 1 other identifier: Hany Saad
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gestational Diabetes; Pre-Gestational Diabetes; IUGR; Macrosomia, Fetal

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• The diagnostic value of cerebroplacental ratio (CPR) in predicting adverse perinatal outcome among diabetic pregnant patients.

  within 24 hours before delivery

• The diagnostic value of ductus venosus Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients.

  within 24 hours before delivery

Study Arms (2)

good perinatal outcome

Fasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler

Diagnostic Test: Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study

poor perinatal outcome

Fasting blood sugar 2 hours postprandial HBA1C Ultrasound and Doppler

Diagnostic Test: Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study

Interventions

Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study DIAGNOSTIC_TEST

Fasting blood sugar, 2 hours postprandial, HBA1C ,Ultrasound and Doppler study

good perinatal outcome; poor perinatal outcome

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: pregnant female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

140 pregnant women, will be recruited from emergency and inpatients departments.

You may qualify if:

• The included women age will range between 18 and 35 years old.
• They will carry 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).
• known to be diabetic in the current pregnancy (PGDM or GDM).

You may not qualify if:

• Women with other maternal medical disorders that may affect perinatal outcome rather than diabetes were excluded from the study.
• women with pre-labour rupture of membrane.
• antepartum hemorrhage, fetuses with congenital anomalies .
• who will receive respiratory depressants (e.g., opioid analgesics) within 2 hours of delivery.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo University

Cairo, 02, Egypt

RECRUITING

Kasr Alainy hospital (Faculty of Medicine-Cairo University)

Cairo, 11956, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Fetal Macrosomia

Interventions

Postprandial Period; Echocardiography, Doppler

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Ultrasonography, Doppler; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Hany Saad, MD

  Kasr Alainy Hospital(Faculty of Medicine -Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany Saad, MD

CONTACT

01001817211; hanysaad25280@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: June 8, 2022
• Study Start: June 15, 2022
• Primary Completion: September 20, 2022
• Study Completion: October 20, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

EG (2)