Protocol summary
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Study aim
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Comparison of pregnancy outcome and glycemic control between insulin versus insulin plus metformin in management of gestational diabetes
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Design
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In this randomized clinical trial, 60 patients with GDM were enrolled. Patients were divided into 2 groups. In the first group, with 20 patients, if despite insulin proper diet, FBS is still above 100, metformin begins. In the second group with 40 patients, if FBS is high, insulin dose is increased and metformin is not given.
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Settings and conduct
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In this study, all pregnant women with a diagnosis of gestational diabetes who are referred to the midwifery clinic of Shiraz University of medical sciences in order to continue their post-natal care will be considered as a statistical society, among which A randomized sample of 60 pregnant mothers with inclusion criteria and without exclusion will be included in the study
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Single-pregnancy pregnancy Gestational age 20-34 weeks FBS is higher than 100 mg/dL, Age range 18 to 40 years. Exclusion criteria: Diagnosis of pre-pregnancy diabetes, presence of metabolic disorders in the patient Need to start treatment with insulin in oral treatment patients, dissatisfied to cooperate in the study, metabolic disorder in the patient, Gestational Hypertension .
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Intervention groups
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In the first group, with 40 patients, if despite insulin proper diet, FBS is still above 100, metformin begins. In the second group with 40 patients, if FBS is high, insulin dose is increased and metformin is not given.
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Main outcome variables
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Results of glucose tolerance test after delivery
General information
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Reason for update
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sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140317017035N5
Registration date:
2020-05-04, 1399/02/15
Registration timing:
retrospective
Last update:
2020-05-13, 1399/02/24
Update count:
1
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Registration date
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2020-05-04, 1399/02/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-07-09, 1397/04/18
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Expected recruitment end date
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2018-09-21, 1397/06/30
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Actual recruitment start date
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2018-07-09, 1397/04/18
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Actual recruitment end date
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2018-09-21, 1397/06/30
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Trial completion date
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2018-09-21, 1397/06/30
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Scientific title
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Comparison of pregnancy outcome and glycemic control between insulin versus insulin plus metformin in management of gestational diabetes.
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Public title
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Comparison of the effect of two regimens of metformin and insulin on glucose tolerance test
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Single-pregnancy
Gestational age 20-34 weeks
FBS is higher than 100 mg/dL
Age range 18 to 40 years
Exclusion criteria:
Diagnosis of pre-pregnancy diabetes, presence of metabolic disorders in the patient Need to start treatment with insulin in oral treatment patients
Dissatisfied to cooperate in the study
Metabolic disorder in the patient
Gestational Hypertension
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use similar pocket
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study is a double-blind, so that the patient and the person providing the medication to the patient and the person analyzing the data do not know the type of treatment used for each person.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-07, 1397/04/16
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Ethics committee reference number
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IR.SUMS.MED.REC.1397.167
Health conditions studied
1
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Description of health condition studied
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Gestational Diabetes
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ICD-10 code
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O24.41
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ICD-10 code description
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Gestational diabetes mellitus in pregnancy
Primary outcomes
1
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Description
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Control of serum glucose level in pregnant women with gestational diabetes mellitus
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Timepoint
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On average checked twice at week 36
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Method of measurement
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Oral Glucose Tolerance Test
2
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Description
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Blood sugar levels
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Timepoint
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1 hour after birth
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Method of measurement
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Glucometer
Secondary outcomes
1
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Description
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Neonate weight
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Timepoint
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After birth
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Method of measurement
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scale
2
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Description
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Apgar score
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Timepoint
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First and fifth minutes after birth
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Method of measurement
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Apgar score scale
Intervention groups
1
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Description
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Intervention group: In first group of intervention, if the blood suger is not controlled with diet. Initially, insulin will be started at 0.5_1 unit per kg, and then if it need, more glucophage (Actoverco factory) and insulin detemir will be added intermittently . The maximum dose of glucophage is up to 2000 mg. changes in oral and injectable medication will be continued for up to 36 weeks in permited manner, if its necessary . To minimize the hypoglycemic effect in infants the glucophage will reduce by one every 4 days from week 36 onwards.
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Category
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Treatment - Drugs
2
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Description
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Control group: In group two of intervention, if the blood suger is not controlled with diet. Initially, insulin will be started at 0.5_1 unit per kg, and then if it need, more insulin detemir will be added intermittently.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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IPD: 2019 Ethic form: 2019
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To whom data/document is available
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IPD: Researcher & Patient Ethic form: Patient
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Under which criteria data/document could be used
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IPD: Ethic form: Awareness of test results
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From where data/document is obtainable
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IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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IPD: Vice chancellery Ethic form: Vice chancellery
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Comments
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