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

NCT ID: NCT02586922

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Three-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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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dr mohamed laban

Professor Mohamed Laban

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Laban, Professor

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Other Identifiers

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LVPT

Identifier Type: -

Identifier Source: org_study_id

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