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

Completed

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT02586922
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-27
• Study Start: 2015-11
• Primary Completion: 2017-06
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-16
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
• Neonatal mortality rate	One week after delivery	- Follow up for early neonatal mortality rate after Neonatal Intensive Care Unit admission