Fetal Distress Clinical Trial
Official title:
Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers
Verified date | May 2017 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | May 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
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 . |
Country | Name | City | State |
---|---|---|---|
Egypt | Women Health Hospital - Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | APGAR score | 5 minutes |
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