Comparison of the effect of metformin with insulin on maternal and neonatal outcomes in women with gestational diabetes

Determining the effect of metformin with insulin on maternal and neonatal outcomes in women with gestational diabetes

A controlled, parallel-group, single-blind, randomized, phase 2-3 clinical trial on 132 patients. The random generator was used for randomization

This single-blind study will be conducted on pregnant women with gestational diabetes in Al-Zahra Hospital, Rasht, Iran. One group will be randomly prescribed metformin and the other group will be prescribed short-acting and long-acting insulin until the end of pregnancy. The patient and the attending physician are aware of the type of treatment, but the outcome assessor is unaware of the allocation of groups.

The inclusion criteria for the study will include all singleton pregnant women aged 20-45 with gestational diabetes after 26 weeks. The exclusion criteria for the study include overt diabetes, fasting sugar more than 120 mg/dL.

In the intervention group, oral administration of metformin 500 mg tablets (Tehran Chemie Pharmaceutical co.) once a day and in the 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

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.

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.

All data is potentially shareable after de-identifying individuals

The access period starts 6 months after the results are published

The data will be available to researchers working in academic and scientific institutions

Signing a contract between two parties

Dr. Seyedah Hajar Sharmi sharami@gums.ac.ir

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.