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IRCT20220215054031N1 IRCT 2022-04-14 Shahid Beheshti University of Medical Sciences Insulin treatment method after corticosteroid treatment in preterm labor A clinical trial: Comparison of two insulin increasement methods in control of blood glucose in pregnant women with diagnosed diabetes on insulin therapy after betamethasone administration due to threatened preterm labor entering Mahdie hospital between 2021-2022: sliding method with increasing patient’s baseline insulin method 2022-04-14 anticipated 34 Complete https://irct.ir/trial/62180 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization Permuted: Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. Blocking is done in two ways: In the first method, the size of all blocks is equal (for example, in a two-group experiment, 8 blocks consist of 4 participants in the intervention group and 4 participants in the control group). In the second method, the size of all blocks is randomly selected (for example, blocks of 8, 6, 10, and 14 in which there are equal numbers of each group in each block). One of the potential problems in the blockchain method is the disclosure of the last allocation in each block. This problem occurs when the study uses the block-blocking method with fixed blocks and also does not use blinding. For example, in blocks of 4, where two allocations to the intervention group and two allocations to the control group are considered, the last allocation will be predictable when the first three allocations are revealed during sampling. Of course, this problem will be solved by randomly selecting the size of the blocks. For example, Hollingworth et al. Used random blocks 2, 4, or 6 for blocking, while Wong et al. Used only 6 blocks in their study, Blinding description: The study is double-blind, and the patient and the nurse who injects the patient with insulin are unaware of which group the patient belongs to. Written consent will be obtained from all patients to participate in the study. Patients are then divided into two random groups and will not be informed which group they are in. Given that the medication received by the patient in the two groups will not change from before and only the insulin dose adjustment is different in the two study groups, the patient is aware that his blood sugar will be controlled with insulin (the patient has already used insulin to control blood sugar). However, the dose of insulin received and the method of increasing it will not be announced to them each time they receive the drug. 2 Condition 1: Gestational diabetes mellitus on insulin therapy. Condition 2: Overt diabetes mellitus in pregnancy. Condition 3: Pre term labor. Intervention 1: Intervention group: In this group we add up 20% of their basal long or intermediate acting insulin at first night after betamethasone injection, for the second and third day we add 30% to the basal insulin and 20% for the fourth day and 10% for the fifth day. Blood sugar is monitored in fasting and premeal and 1 hour after each meal and at 12 and 3 am. Based on Pre meal blood sugar level, short acting insulin is increased each time; is blood sugar is between 100-120, 1 unit is added to the short acting insulin and if blood sugar is over 120, 2 units is added per 10 mg/dl. And if blood sugar is over 140, 1 unit per 10mg/dl is added to the short acting insulin. Short acting regular insulin made in Iran, Exir cmpany, NPH intermediate acting insulin, made in Iran, Exir cmpany, betamethasone made in Iran, Caspian company. Intervention 2: Control group: 12 hours after first betamethasone injection, blood sugar will be measured hourly and if it is over 120mg/dl, 1 unit of regular insulin per each 20 mg/dl blood sugar will be added to their routine insulins. Yes - There is a plan to make this available What will be shared: All results and IPD collected for the primary outcome measure will be shared. When: 6 month after publication To whom: Data is available for people working in academic institutions. Conditions: After getting permission from the researcher, data could be used for meta-analysis. Where to obtain: Via Fateme Samadi Nasab's Email address How to obtain: An Email must be sent to the researcher in Persian or English and the need for data and analysis must be explained. Comments:
public Fateme Samadi Nasab
Koodakiar
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 faf.samadinasab@gmail.com Shahid Beheshti University of Medical Sciences scientific Fateme Samadi Nasab
Koodakiar
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 faf.samadinasab@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Gestational age between 24 to 34 weeks Gestational diabetes on insulin therapy Diabetes type 1 or 2 on insulin therapy Completely controlled blood sugar before entrance to trial Corticosteroid therapy before labor Multiple pregnancy no limit no limit Female Patients unwilling to enter or continue the study Patient refusing admission in our hospital O24.414 E08 O60 Gestational diabetes mellitus in pregnancy, insulin controlled Diabetes mellitus due to underlying condition Preterm labor Treatment - Drugs Treatment - Drugs Intervention group: In this group we add up 20% of their basal long or intermediate acting insulin at first night after betamethasone injection, for the second and third day we add 30% to the basal insulin and 20% for the fourth day and 10% for the fifth day. Blood sugar is monitored in fasting and premeal and 1 hour after each meal and at 12 and 3 am. Based on Pre meal blood sugar level, short acting insulin is increased each time; is blood sugar is between 100-120, 1 unit is added to the short acting insulin and if blood sugar is over 120, 2 units is added per 10 mg/dl. And if blood sugar is over 140, 1 unit per 10mg/dl is added to the short acting insulin. Short acting regular insulin made in Iran, Exir cmpany, NPH intermediate acting insulin, made in Iran, Exir cmpany, betamethasone made in Iran, Caspian company. Control group: 12 hours after first betamethasone injection, blood sugar will be measured hourly and if it is over 120mg/dl, 1 unit of regular insulin per each 20 mg/dl blood sugar will be added to their routine insulins. Blood sugar of patient. Timepoint: For 5 days after betamethasone injection. Method of measurement: Glucometer with milligrams per deciliter scale. Hypoglycemic events. Timepoint: During 5 days after betamethasone injection. Method of measurement: Blood sugar lower than 60 mg/dl. Diabetic ketoacidosis: is the combination of high blood sugar and low insulin levels that cause increased ketone body products. Timepoint: During 5 days after betamethasone injection. Method of measurement: Blood sugar with glucometer, Arterial blood gasses assays acidosis and urinary ketone assays with dipstick test. Insulin units increased during 5 days. Timepoint: 5 days after betamethasone injection. Method of measurement: International unit. Shahid Beheshti University of Medical Sciences Approved 2022-02-18 Ethics committee of Shahid Beheshti University of Medical Sciences Koodakiar Tehran Tehran Iran (Islamic Republic of)