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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02586922
• Collaborator: (none)
• Enrollment: 70
• Actual Duration (Months): 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome	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 Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy and Their Correlation With Neonatal Outcome: a Pilot Study
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Outcome Measures

Primary Outcome Measures

1. neonatal respiratory distress [immediately after delivery]

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

Secondary Outcome Measures

1. • Neonatal mortality rate [One week after delivery]

   - Follow up for early neonatal mortality rate after Neonatal Intensive Care Unit admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: dr mohamed laban, Professor Mohamed Laban, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02586922
• Other Study ID Numbers: LVPT
• First Posted: Oct 27, 2015
• Last Update Posted: Jul 19, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Pregnancy in Diabetics

Study Results

No Results Posted as of Jul 19, 2017