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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02586922

Enrollment

Registered

2015-10-27

Start date

2015-11-30

Completion date

2017-07-31

Last updated

2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome

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.

Interventions

DEVICEThree-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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
neonatal respiratory distress	immediately after delivery	Occurrence of neonatal respiratory distress immediately after delivery utilizing APGAR score at birth in numbers

Secondary

Measure	Time frame	Description
• Neonatal mortality rate	One week after delivery	\- Follow up for early neonatal mortality rate after Neonatal Intensive Care Unit admission

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026