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IRCT20080826001096N9 IRCT 2022-10-19 Rasht University of Medical Sciences Comparing the effect of metformin with insulin on gestational diabetes Comparison of the effect of metformin with insulin on maternal and neonatal outcomes in women with gestational diabetes 2022-10-22 anticipated 132 Complete https://irct.ir/trial/64597 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, random sequences will be generated using the Random generator program. Based on the method of random blocks and considering blocks of four, 33 blocks will be produced for 132 patients. After generating the list, each person will be assigned a unique code and will be identified with this code during the study. Allocation concealment will be done using sealed envelopes (SNOSE). Based on the size of the research sample, several aluminum envelopes will be prepared and each of the randomly generated sequences will be recorded on a card and the cards will be placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lid of the envelopes will be glued and will be placed in a box respectively. At the start of the intervention, the envelopes are opened in order and the assigned group of that participant is revealed, Blinding description: People evaluating the outcome (evaluators) and analyzing the results do not know the type of treatment assigned to the patient. In fact, the data analysis will be done by a statistics and epidemiology expert, without knowing what treatment the patients in group A and B have received. Also, a gynecology resident (outcome assessor) will measure and record the primary and secondary outcomes of patients in both groups without knowing that patient has received metformin or insulin treatment. 2-3 Diabetes mellitus in pregnancy. Intervention 1: Intervention group: Administration of oral metformin 500 mg tablets (Tehran Chemie Pharmaceutical co.) once a day until the end of pregnancy. Intervention 2: Control group: Subcutaneous administration of long-acting insulin (Detmir or Lumir, Novo Nordisk) at a dose of 0.5-1 unit per kilogram once at night, in patients with high fasting blood sugar and in cases of high post-meal blood sugar, administration of short-acting insulin (Aspart or Novorpid, Novo Nordisk) at a dose of 0.5-1 unit per kilogram before each meal until the end of pregnancy. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions Conditions: Signing a contract between two parties Where to obtain: Dr. Seyedah Hajar Sharmi sharami@gums.ac.ir How to obtain: After contacting Dr. Sharami via email or phone call, and if possible, a face-to-face meeting, and after the contract is signed, the data will be available. Comments:
public Seyedeh Hajar Sharami
Al-Zahra Hospital, Namjoo St
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3336 9224 sharami@gums.ac.ir Rasht University of Medical Sciences scientific Seyedeh Hajar Sharami
Al-Zahra Hospital, Namjoo St
Rasht Iran (Islamic Republic of) 4144654839 001333369224 sharami@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Pregnant women with singletons Having gestational diabetes after 26 weeks 20 years 45 years Female Having overt diabetes Having fasting sugar more than 120 mg/dL Having blood sugar one hour after a meal above 200 mg/dL Having chronic diseases of the digestive system Having a contraindication use for metformin O24.9 Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium Treatment - Drugs Treatment - Drugs Intervention group: Administration of oral metformin 500 mg tablets (Tehran Chemie Pharmaceutical co.) once a day until the end of pregnancy Control group: Subcutaneous administration of long-acting insulin (Detmir or Lumir, Novo Nordisk) at a dose of 0.5-1 unit per kilogram once at night, in patients with high fasting blood sugar and in cases of high post-meal blood sugar, administration of short-acting insulin (Aspart or Novorpid, Novo Nordisk) at a dose of 0.5-1 unit per kilogram before each meal until the end of pregnancy. Blood sugar. Timepoint: Fasting before the intervention and one hour after the intervention weekly until the end of pregnancy. Method of measurement: Glucometer. Maternal hypoglycemic episodes. Timepoint: Fasting before the intervention and one hour after the intervention weekly until the end of pregnancy. Method of measurement: Glucometer. Blood pressure disorders in pregnancy. Timepoint: Monthly visit after the start of the intervention. Method of measurement: Sphygmomanometer. Preterm delivery. Timepoint: Postpartum. Method of measurement: Delivery earlier than 37 weeks of pregnancy. Intrauterine fetal death. Timepoint: Weekly visit after the start of the intervention. Method of measurement: Absence of fetal heartbeat in ultrasound. Polyhydramnios. Timepoint: Weekly visit after the start of the intervention. Method of measurement: Sonography. Macrosomia. Timepoint: Postpartum. Method of measurement: scales. Nneonatal hypoglycemia. Timepoint: After birth. Method of measurement: Bleeding of the heel. Shoulder dystocia. Timepoint: During childbirth. Method of measurement: Observation. Respiratory distress syndrome. Timepoint: Weekly visit after the start of the intervention. Method of measurement: Neonatal specialist report. Need for Neonatal Intensive Care Unit. Timepoint: After birth. Method of measurement: Neonatal specialist report. Metformin side effects. Timepoint: Immediately after intervention and weekly follow-up. Method of measurement: Patient report. Rasht University of Medical Sciences Approved 2022-06-29 Ethics Committee of Guilan University of Medical Sciences Research and Technology Vice-Chancellor of Gilan University of Medical Sciences., Namjoo St Rasht Guilan Iran (Islamic Republic of)