Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy

The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

About this study

Research question:

Can the assessment of fetal lung volume by Virtual Organ Computed-aided Analysis (VOCAL) and pulmonary artery resistance index by pulsed Doppler predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers?

Research hypothesis:

The assessment of fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler can predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-Diabetic pregnant women 38 weeks gestation admitted for elective termination due to various obstetric indications

Exclusion criteria

Twins.
Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc).
Autoimmune disorders.
Congenital fetal anomalies.
Macrosomia and intrauterine growth restriction (IUGR).
Intrauterine fetal death (IUFD).
Amniotic fluid index <5cm or >20cm.
Patients taking steroids within one week of measurement of lung volume.

Treatment and study plan

Three-dimensional (3D) ultrasonography

Device

A longitudinal section of fetal chest will be obtained that clearly depicts the lung. A 3D window will be activated . After complete electronic sweep and assurance of absence of fetal or maternal movements to avoid motion artifacts, 3D multi-planar view will be then obtained

Primary outcomes

neonatal respiratory distress

Time frame: immediately after delivery

Occurrence of neonatal respiratory distress immediately after delivery utilizing APGAR score at birth in numbers

Secondary outcomes

• Neonatal mortality rate

Time frame: One week after delivery
- Follow up for early neonatal mortality rate after Neonatal Intensive Care Unit admission

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy and Their Correlation With Neonatal Outcome: a Pilot Study

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Oct 27, 2015
Registry last updated: Jul 19, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed