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NCT02586922 Clinical Trial

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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02586922
Other study ID # LVPT
Secondary ID
Status Completed
Phase N/A
First received October 22, 2015
Last updated July 16, 2017
Start date November 2015
Est. completion date July 2017

Study information
Verified date July 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

1. Twins.

2. Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc).

3. Autoimmune disorders.

4. Congenital fetal anomalies.

5. Macrosomia and intrauterine growth restriction (IUGR).

6. Intrauterine fetal death (IUFD).

7. Amniotic fluid index <5cm or >20cm.

8. Patients taking steroids within one week of measurement of lung volume.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Three-dimensional (3D) ultrasonography
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary neonatal respiratory distress Occurrence of neonatal respiratory distress immediately after delivery utilizing APGAR score at birth in numbers immediately after delivery
Secondary • Neonatal mortality rate - Follow up for early neonatal mortality rate after Neonatal Intensive Care Unit admission One week after delivery
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