Comparison of oral antidiabetic drugs with insulin in the treatment of Gestational Diabetes Mellitus.
Phase 3
Completed
- Conditions
- Gestational Diabetes MellitusMetabolic and Endocrine - DiabetesReproductive Health and Childbirth - Fetal medicine and complications of pregnancy
- Registration Number
- ACTRN12612001272886
- Lead Sponsor
- Dr Aisha Syed Wali
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 154
Inclusion Criteria
Women diagnosed as GDM, according to criteria given in the protocol.
Singleton pregnancy.
Women who consented for study.
Exclusion Criteria
Pre-gestational type 1 and type 2 diabetes mellitus
Overt diabetes (FBG > or equal to 126 mg/dl, Hb A1C > or equal to 6.5%)
Gestational age > 33 weeks at the time of recruitment.
Patients on steroid therapy
Women not tolerating Oral Glucose Tolerance Test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method As per standard care women did self monitoring of blood glucose (SMBG) and maintained record of SMBG. This data was recorded on excel files. The outcome was assessed from determining average fasting blood glucose (FBG) and average post meal blood glucose recorded in excel files, for (a) 15 days prior to delivery (b) from recruitment to delivery. Following criteria was used for judgement of glycemic control: Excellent control - FBG < 95 mg/dl, Post Prandial < 120 mg/dl Satisfactory control - FBG 95 - 110 mg/dl, Post Prandial 120 - 140 mg/dl. Uncontrolled - FBG > 110 mg/dl, Post Prandial > 140 mg/dl.[At the time of admission in the hospital for child birth average blood sugars over 15 days prior to delivery will be calculated from the SMBG chart, as mentioned above.]
- Secondary Outcome Measures
Name Time Method Acceptability to treatment will be assessed on structured questionairre.[Before discharge of the subject from hospitalization for child birth.];Cost of treatment. The clinical trial unit pharmacy of Aga Khan University will maintain drug log for each subject. The pharmacy will calculate the cost from this log.[Cost will be calculated at the end of study period of that particular subject.]