Determination of the effect of metformin and insulin in the treatment of pregnant women with gestational diabetes
Design
Clinical trial, with randomized groups, phase 4, on 100 patients, for randomization from the table of random numbers, the sample size has been done with the help of stata11 software.
Settings and conduct
The location of the study is Shohada Tajrish Hospital, Tehran. At the beginning of the study, the variables related to the mother are measured. Then they are divided into two groups of insulin and metformin and receive the prescribed doses, and the dose is adjusted according to fasting and postprandial sugar levels. Treatment of side effects as well as therapeutic doses and prescription drugs are also recorded.
Participants/Inclusion and exclusion criteria
All participating pregnant women must have one of the following:
Fasting blood glucose (92-125 mg/dl 1-hour blood glucose ≥ 180 mg/dl;
2-hour blood glucose (153-199 mg/dl) After 75 grams of oral glucose;
Exclusion criteria: women for whom the use of metformin is contraindicated؛diagnosed fetal anomaly or rupture of membranes at the time of entering the study؛ and the presence of any other medical condition.
Intervention groups
Pregnant women treated with insulin and pregnant women treated with metformin
Main outcome variables
Age at termination of pregnancy؛ Birth weight Apgar 5 minutes؛ Incidence of birth defects؛ Rate of hospitalization in NICU؛ Rate of pre-eclampsia Cesarean section rate؛ dystocia of the infant's shoulder؛ Incidence of infant hypocalcemia؛ Need for phototherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220817055738N1
Registration date:2022-10-04, 1401/07/12
Registration timing:retrospective
Last update:2022-10-04, 1401/07/12
Update count:0
Registration date
2022-10-04, 1401/07/12
Registrant information
Name
Golshan Noorollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3379 0310
Email address
gnurollahiii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
2020-09-22, 1399/07/01
Actual recruitment end date
2020-12-20, 1399/09/30
Trial completion date
2021-09-22, 1400/06/31
Scientific title
Comparison of Pregnancy outcomes in women with gestational diabetes treated with metformin and insulin
Public title
Comparison of the therapeutic effect of metformin and insulin in diabete
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood glucose (92-125 mg/dl),,
1-hour blood glucose ≥ 180 mg/dl after 75 grams of oral glucose
2-hour blood glucose (153-199 mg/dl) after 75 grams of oral glucose
Exclusion criteria:
Women for whom metformin is contraindicated
Diagnosed fetal anomaly
Rupture of the fetal membrane at the time of entering the study
Presence of any other medical condition
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
99
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were selected by simple random sampling method and divided into study groups using the table of random numbers.To use the table of random or random numbers, we first defined the framework of our statistical society; That is, we found out the exact number of people in the society and gave them a code or machine gun number respectively. To select sample people from the table, we randomly started from a point in the table in the row or column direction. After this, we checked the route numbers. We came across two types of numbers, one of which was smaller than the number of the studied community and the other was larger than the number of the community. We chose to consider only the smaller numbers.The selected number is actually the code of an individual from the community that is selected as a sample. We continued this work until we could choose a small number for the number of sample people. After the sample volume was completed, the sampling work was completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No 129، Golsar 2 Ave، Keshavarz Blvd، Ardabil city
City
Ardabil
Province
Ardabil
Postal code
5615616419
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.SBMU.MSP.REC.1401.007
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
blood sugar level
Timepoint
Fasting blood sugar and postprandial blood sugar of the participants were monitored weekly. A comparison of the blood sugar level measured with a glucometer and plasma blood sugar was made to check the accuracy of the stated blood sugar level.
Method of measurement
Glucometer and plasma blood sugar
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the insulin group, if the fasting blood glucose was high, NPH insulin was prescribed at the rate of 0.2 units per kilogram before going to bed. If the postprandial blood glucose was high, regular insulin was given before meals based on the postprandial glucose level, at a rate of 1 unit for every 10 mg/dL above target. If both fasting and postprandial glucose levels were high, a total dose of 0.7 units/kg was started. Insulin was divided into two doses, morning and evening. The morning dose of two-thirds of NPH insulin was divided into one-third as regular insulin injection before meals if necessary, and at night, one-half of NPH and one-half of regular insulin. Adjustment of insulin dose depending on capillary blood glucose level was done based on four glucose measurements during the day.
Category
Treatment - Drugs
2
Description
Intervention group: The women in the metformin group received an initial dose of 500 mg twice a day, and it was increased by 500-1000 mg every two weeks in order to achieve the target blood sugar, and up to a maximum daily dose of 2500 mg in divided doses. increased in meals. Metformin was continued until delivery. If blood sugar control was not achieved despite the maximum dose of metformin, insulin was added.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran, Shahada Tajrish Hospital
Full name of responsible person
Golshan Noorollahi
Street address
No 129، Golsar 2 Ave، Keshavarz Blvd، Ardabil City
City
Tehran
Province
Tehran
Postal code
5615616419
Phone
+98 45 3379 0310
Email
gnurollahiii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behrooz Abtahi
Street address
Tehran؛ Evin؛ Shahid Shahriari Square؛ Shahid Beheshti University
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Fax
+98 21 2243 1607
Email
pr-office@sbu.ac.ir
Web page address
https://sbu.ac.ir/web/RESVP
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golshan Noorollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 129، Golsar2 Ave، Keshavarz Blvd، Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5615616419
Phone
+98 45 3379 0310
Fax
Email
gnurollahiii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golshan Noorollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 129، Golsar2 Ave، Keshavarz Blvd، Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5615616419
Phone
+98 45 3379 0310
Fax
Email
gnurollahiii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golshan Noorollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 129، Golsar2 ave، Keshavarz Blvd، Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5615616419
Phone
+98 45 3379 0310
Fax
Email
gnurollahiii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available