Overview

Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.

Status:
Completed
Trial end date:
2020-03-29
Target enrollment:
0
Participant gender:
Female
Summary
A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kasr El Aini Hospital
Collaborators:
Amal Kotb Abdallah
Amir Gabr
Mohamed Abdeltawwab Mahmoud
Treatments:
Insulin
Insulin, Globin Zinc
Metformin
Criteria
Inclusion Criteria:

- Diabetic pregnant patients with type one diabetes and no other chronic disorders

- Patients on insulin in the 3rd trimester of pregnancy (on insulin therapy since start
of gestation)

- Patients pregnant in single living fetus with no apparent congenital anomalies

- Haemoglobin A 1 C (HbA1c) level between 7% to 11%

- All patients have done a dating ultrasound to confirm gestational age, viability and
rule out any abnormality

Exclusion Criteria:

- Patients with type 2 or gestational diabetes

- Patients with intolerance or hypersensitivity to metformin

- Patients with congestive heart failure or a history of congestive heart failure

- Patients with renal insufficiency

- Patients having current significant gastrointestinal problems such as severe vomiting
requiring intravenous fluids or hospitalization

- Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis, a
history of diabetic ketoacidosis or history of lactic acidosis

- Patients with liver impairment

- Patients with known higher order pregnancies (twins, triplets, etc.)

- Patients having a known potentially fetal lethal anomaly