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

NCT02586922 | Completed DMC

• 1 other identifier: LVPT
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• neonatal respiratory distress

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

  immediately after delivery

Secondary Outcomes (1)

• • Neonatal mortality rate

  One week after delivery

Interventions

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

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study which will be carried out at Ain Shams University Maternity Hospital, Obstetrics and Gynecology department, Faculty of Medicine, Ain Shams University, from December 2015 to December 2016. Diabetic pregnant women 38 weeks gestation admitted for elective termination by Caesarian section due to various obstetric indications

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mohamed Laban, Professor

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Mohamed Laban

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 27, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07