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Completed

NCT Number: NCT02643225

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

The aim of this work is the prediction of fetal macrosomia by measuring:

1. HbA1C. 2. Umbilical cord thickness. 3. Interventricular septum thickness.

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Key information

About this study

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:

  • 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.

  • 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.

  • HbA1c levels will be measured for diabetes patients.

All the patients will be subjected to :

  • Full history taking including last menstrual period, medical history and past obstetric history.
  • Detailed general physical history examination and obstetrics examination.
  • Ultrasound examination in fetal medicine unit maternity hospital Ain shams university.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton gestation.
  • Gestational age over 27 weeks.
  • Intact membranes.
  • Normal umbilical morphology (two arteries and one vein).
  • Diagnosis of gestational diabetes.

Exclusion criteria

  • The presence of fetal congenital anomalies.
  • Multifetal pregnancy.
  • Maternal chronic diseases (hypertension, renal disease, cardiac and pulmonary disease, etc.).
  • Patients with a diagnosis such as oligohydramnios , pre-eclampsia and intrauterine growth retardation.
  • Patients who used cigarettes or alcohol during pregnancy.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Role of Umbilical Cord Thickness, Interventricular Septum Thickness and HbA1C Levels in Prediction of Fetal Macrosomia in Patients With Gestational Diabetes Mellitus

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2015
Registry last updated
Aug 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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