Status:
COMPLETED
Comparative Effects of Metformin and Insulin on Stereological Studies and Immunohistochemistry of Placenta
Lead Sponsor:
University of Karachi
Conditions:
Diabetes Mellitus Arising in Pregnancy, Insulin-Requiring
Diabetes Mellitus in Pregnancy
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Diabetes mellitus is a group of metabolic disorder characterized by high blood glucose level mainly due to defect in insulin secretion or resistance. In pregnancy, insulin resistance increases as the ...
Detailed Description
Diabetes mellitus is a group of metabolic disorder with relative or absolute deficiency of insulin. Pregnancy is a potentially glucose intolerant condition as insulin sensitivity decreases with the pr...
Eligibility Criteria
Inclusion
- For this study placentae were collected from:
- Patients who were diagnosed as GDM during second trimester screening for FBS and RBS, confirmed further by OGCT and OGTT.
- GDM patients who signed the written informed consent.
- GDM patients who were in ages between 18 years and 40 years and had no other comorbid such hypertension, CVD etc
- Full term GDM patients with singleton pregnancy (37 weeks and above)
- GDM patients whose placenta were preserved within 30-40 minutes of delivery.
Exclusion
- Placentae were not collected from:
- GDM Patients with ages less than 18 or more than 40 years
- GDM females with some co-morbid and complications (e.g. hypertension, CVD, diabetes type 1 or diabetes type 2 before gestation, abnormal Urea Creatinine Electrolyte (UCE) and Liver function test (LFTs).
- GDM Patients who delivered pre-termed (\< 37 weeks of gestation) or post termed (\>42 weeks of gestation)
- GDM patients with twin pregnancy.
- GDM Patients if not preserved in the formalin properly within 30-40 minutes of delivery.
- GDM females who were given combined (Metformin and insulin) therapy.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04907708
Start Date
January 1 2018
End Date
August 7 2019
Last Update
June 1 2021
Active Locations (1)
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1
Jinnah Post Graduate Medical Centre
Karachi, Sindh, Pakistan, 75510