Status:
COMPLETED
Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin
Lead Sponsor:
Ain Shams University
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
19-35 years
Phase:
PHASE3
Brief Summary
Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high ...
Eligibility Criteria
Inclusion
- Patients aged (19-35) years
- BMI 18-30 kg/m2
- Gestational age \>24 weeks
- Singleton pregnancy
- Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG \> 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.
Exclusion
- Pregnant women with preexisting diabetes mellitus
- Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
- Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
- Fetal anomalies identified on ultrasound prior to initiation of therapy.
- Patients who refused to participate
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2019
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03841591
Start Date
February 1 2018
End Date
January 15 2019
Last Update
February 15 2019
Active Locations (1)
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1
Ain SHams Maternity Hospital
Cairo, Abbaseya, Egypt, 002