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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: Three-dimensional (3D) ultrasonography

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 Type: Observational
• Enrollment (Actual): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mohamed Laban, Professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 16, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Pregnancy in Diabetics
• Other Study ID Numbers: LVPT