Back to resultsMaternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Insulin
Metformin
Assessment of weight gain
Sponsored by
About this trial
This is an interventional other trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Ain SHams Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Insulin Group
Metformin Group
Arm Description
This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.
This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.
Outcomes
Primary Outcome Measures
Rate of maternal weight gain per week
Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.
Secondary Outcome Measures
1-min APGAR score
APGAR score at minute 1 after delivery
5-min APGAR score
APGAR score at minute 5 after delivery
Incidence of neonatal hypoglycemia
Number of neonates with two or more neonatal glucose value <2.6 mmol per liter during the first day after delivery.
Incidence of neonatal respiratory distress
Number of neonates needing at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery.
Incidence of macrosomia
Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age
Full Information
NCT ID
NCT03841591
First Posted
February 13, 2019
Last Updated
February 13, 2019
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03841591
Brief Title
Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin
Official Title
Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 25, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy.
This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Group
Arm Type
Active Comparator
Arm Description
This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.
Arm Title
Metformin Group
Arm Type
Active Comparator
Arm Description
This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Cidophage
Intervention Description
Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.
Intervention Type
Other
Intervention Name(s)
Assessment of weight gain
Intervention Description
Body weight will be measured monthly from the start of treatment till delivery.
Primary Outcome Measure Information:
Title
Rate of maternal weight gain per week
Description
Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
1-min APGAR score
Description
APGAR score at minute 1 after delivery
Time Frame
1 minute
Title
5-min APGAR score
Description
APGAR score at minute 5 after delivery
Time Frame
5 minutes
Title
Incidence of neonatal hypoglycemia
Description
Number of neonates with two or more neonatal glucose value <2.6 mmol per liter during the first day after delivery.
Time Frame
1 day
Title
Incidence of neonatal respiratory distress
Description
Number of neonates needing at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery.
Time Frame
1 day
Title
Incidence of macrosomia
Description
Number of neonates with birth weight greater than 4000 g or greater than 90% for gestational age
Time Frame
1 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinaa Hamdy, MBBCh
Organizational Affiliation
S Hamdy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain SHams Maternity Hospital
City
Cairo
State/Province
Abbaseya
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin
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