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The Role of Umbilical Cord Thickness in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02643225
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Rehab Mohamed Abdelrahman, Ain Shams University

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.

Condition or disease
Gestational Diabetes

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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Umbilical Cord Thickness, Interventricular Septum Thickness and HbA1C Levels in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus
Study Start Date : April 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Group/Cohort
pregnant women with gestational diabetes
case group
non diabetic pregnant women
control group



Primary Outcome Measures :
  1. The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight) [ Time Frame: at birth ]
    The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.


Secondary Outcome Measures :
  1. Umbilical Cordcross-sectional Area [ Time Frame: 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.

  2. Prediction of Fetal Macrosomia by Measuring HbA1C in Participants [ Time Frame: 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.

  3. Interventricular Septum Thickness [ Time Frame: 36-37 weeks of gestation ]
    The interventricular septum thickness will be measured by ultrasound examination



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

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Responsible Party: Rehab Mohamed Abdelrahman, Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02643225    
Other Study ID Numbers: Diabetes mellitus
First Posted: December 31, 2015    Key Record Dates
Results First Posted: August 18, 2016
Last Update Posted: August 18, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Diabetes, Gestational
Fetal Macrosomia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Fetal Diseases
Pregnancy in Diabetics
Diabetes Complications
Birth Weight
Body Weight
Signs and Symptoms