Fetal Interventricular Septum Thickness and Maternal Gestational Diabetes Control

NCT03654521 | Unknown DMC

• 1 other identifier: 0580-17-RMB
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Glucose intolerance and gestational diabetes are common complications of pregnancy. Their prevalence varies worldwide secondary to differences in screening practices (one-step versus two-step approach) and population characteristics (increased maternal age, body mass index, ethnicity). Gestational diabetes mellitus is associated with increased incidence of macrosomia, operative vaginal delivery, shoulder dystocia, cesarean delivery, metabolic complications in the newborn and long-term risk of developing type II diabetes mellitus (HAPO 2008). Early diagnosis and management of gestational diabetes mellitus, including dietary advice and insulin, improves maternal and fetal outcomes (Crowther 2005, Hartling 2013). Various strategies have been tested prenatally to detect those fetuses that might be adversely affected by gestational diabetes mellitus. For instance, the abdominal circumference measurement during routine fetal biometry was used successfully to identify pregnancies with a higher risk of fetal macrosomia (Schaefer-Graf 2003, De Reu 2008, Rosati 2010). In recent years, the fetal interventricular septum thickness, as detected by two-dimensional ultrasound, was shown to be significantly thicker in the presence of gestational diabetes mellitus, independently of maternal glycemic control, when compared to pregnancies with no gestational diabetes mellitus (Ren 2011, Garg 2014). Current guidelines focus on normalisation of maternal blood glucose concentration. Thus far no study has addressed whether measurement of the fetal interventricular septum thickness can predict adverse pregnancy outcome in euglycemic women with gestational diabetes mellitus.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Fetal interventricular septum thickness

  Differences in fetal interventricular septum thickness in both women with gestational or pre-gestational diabetes mellitus and women without gestational or pre-gestational diabetes mellitus.

  Between 24-34 weeks of gestation.

Study Arms (2)

Diabetes group

ACTIVE COMPARATOR

Women with gestational or pre-gestational diabetes mellitus.

Diagnostic Test: Fetal interventricular septum thickness

Control group

ACTIVE COMPARATOR

Women without gestational or pre-gestational diabetes mellitus.

Diagnostic Test: Fetal interventricular septum thickness

Interventions

Fetal interventricular septum thickness DIAGNOSTIC_TEST

Two-dimensional ultrasound fetal cardiac imaging test

Control group; Diabetes group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Study group - women between 24 - 34 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus.
• Control group - women between 24 - 34 weeks' gestation who do not have diabetes.

You may not qualify if:

• women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

RECRUITING

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

Study Officials

• Yaniv Zipori, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaniv Zipori, MD

CONTACT

0587966963; y_zipori@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: August 1, 2018
• Primary Completion: July 15, 2020
• Study Completion: December 31, 2020
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

IL (1)