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Fetal Interventricular Septum Thickness and Maternal Gestational Diabetes Control

NCT03654521 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2018-08-31

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Fetal interventricular septum thickness

Two-dimensional ultrasound fetal cardiac imaging test

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Yaniv Zipori, MD · Rambam Health Care Campus

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-07-15
Completion
2020-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654521 on ClinicalTrials.gov