Prediction of Fetal Lung Maturity
Primary Purpose
Fetal Distress
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fetal lung volume
pulmonary artery resistance index
Fetal adrenal gland volume:
Sponsored by
About this trial
This is an interventional diagnostic trial for Fetal Distress
Eligibility Criteria
Inclusion Criteria:
- All pregnant diabetic women
- 37 weeks gestational age .
Exclusion Criteria:
- Women before 37 and after 39 weeks gestational age
- Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
- Multiple pregnancies.
- Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
- Women with premature rupture of membranes (prom)
- Pregnancies complicated by medical disorders other than diabetes mellitus .
- Failure to obtain an informed consent .
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diabetic pregnant women
Arm Description
Outcomes
Primary Outcome Measures
APGAR score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03159234
Brief Title
Prediction of Fetal Lung Maturity
Official Title
Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes.
Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Distress
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetic pregnant women
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
fetal lung volume
Intervention Description
the best method for measurement of fetal lung volume is by the rotational technique in which each lung is obtained by serial contouring of the pulmonary area after rotating the volumetric image.this is more recent method seems to have advantages allowing finer contouring of the lung and subsequent modification of the contour as well as being better able to estimate the volumes of irregular and small lung as in congenital diaphragmatic hernia
Intervention Type
Radiation
Intervention Name(s)
pulmonary artery resistance index
Intervention Description
Women placed in semirecumbent position and an axial plane through the fetal thorax to achieve 4 chamber view of the heart. The main pulmonary artery was followed to the point where it divides into right and left branches by rotating the transducer from the 4 chamber view to the short axis view of the heart. Pulsed and colour Doppler was used. The fetal pulmonary artery flow waveform measurements was taken within the proximal portion of the main pulmonary artery
Intervention Type
Radiation
Intervention Name(s)
Fetal adrenal gland volume:
Intervention Description
the adrenal gland has a characteristic sonographic appearance; each limb is seen as a long anechoic structure with a thin, echogenic line within its center . Both limbs can sometimes be seen in the coronal plane, and if so there is a strong echogenic line between limbs (probably fat). On the basis of pathologic and histologic studies , we believe the anechoic bulk of the gland represents the fetal zone of the cortex, while the central echogenic core is the medulla.
Primary Outcome Measure Information:
Title
APGAR score
Time Frame
5 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All pregnant diabetic women
37 weeks gestational age .
Exclusion Criteria:
Women before 37 and after 39 weeks gestational age
Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
Multiple pregnancies.
Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
Women with premature rupture of membranes (prom)
Pregnancies complicated by medical disorders other than diabetes mellitus .
Failure to obtain an informed consent .
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prediction of Fetal Lung Maturity
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