Skip to main content
Clinical Trials/NCT02586922
NCT02586922
Completed
Not Applicable

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

Ain Shams University0 sites70 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome
Sponsor
Ain Shams University
Enrollment
70
Primary Endpoint
neonatal respiratory distress
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
July 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr mohamed laban

Professor Mohamed Laban

Ain Shams University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

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(One week after delivery)

Similar Trials