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

NCT02643225 | Completed Results DMC

• 1 other identifier: Diabetes mellitus
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

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

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)

  The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.

  at birth

Secondary Outcomes (3)

• Umbilical Cordcross-sectional Area

  36-37 weeks of gestation

• Prediction of Fetal Macrosomia by Measuring HbA1C in Participants

  36-37 weeks of gestation

• Interventricular Septum Thickness

  36-37 weeks of gestation

Study Arms (2)

pregnant women with gestational diabetes

case group

non diabetic pregnant women

control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Diabetes, Gestational

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

Results Point of Contact

• Title: Dr.Rehab Mohamed Abdelrahman
• Organization: Ain Shams University

rehababdulrahman.rm@gmail.com

+201004992772

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University

Study Record Dates

• First Submitted: December 26, 2015
• First Posted: December 31, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 18, 2016
• Results First Posted: August 18, 2016

Record last verified: 2016-07