Assessment of the probiotic effectiveness on the rate of gestational diabetes in comparison to placebo in high risk pregnant women referred to Arash Hospital
This study is a double blind randomized, parallel single- center clinical trial which is done in stage two of clinical trial.The aim of this study was to evaluate the effect of probiotic intake on diabetes in pregnancy. Singleton pregnant women aged between 18 -35 year- old enter the study based on inclusion criteria. Our sample size is 572 which are randomly divided into two groups. In intervention group, pregnant women receive probiotic tablets once a day for 10 weeks from 14th week of pregnancy. In control group, placebo is received the same as intervention group. Then, gestational diabetes in both groups is diagnosed by glucose tolerance test. Results of two groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110111020N6
Registration date:2016-12-26, 1395/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Science
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the probiotic effectiveness on the rate of gestational diabetes in comparison to placebo in high risk pregnant women referred to Arash Hospital
Public title
Effect of probiotic in gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnant women in the first trimester; BMI more than 25; family history in the first-degree relatives; history of GDM in previous pregnancy; ovarian poly cystic syndrome; history of IUFD birth; Macrosomia; abortion
Exclusion criteria: diabetes; heart and CNS diseases; using nerve drugs; multiple pregnancy; positive result of 75 grams glucose test in the first visit
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
542
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods Street, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2016-10-25, 1395/08/04
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.857
Health conditions studied
1
Description of health condition studied
gestatinal diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
gestational diabetes
Timepoint
24- 28 weeks of pregnancy
Method of measurement
glucose tolerance test
Secondary outcomes
1
Description
type of delivery
Timepoint
end of pregnancy
Method of measurement
observational
2
Description
Macrosomia
Timepoint
After child birth
Method of measurement
weighting
3
Description
preeclampsia
Timepoint
during pregnancy
Method of measurement
measuring blood pressure and proteinuria
Intervention groups
1
Description
Intervention group: Patients receive probiotic tablets from 14th week of pregnancy for 10 weeks.Then gestational diabetes is diagnosed by GGT in 24 - 28 weeks.
Category
Treatment - Drugs
2
Description
control group: Patients receive placebotablets from 14th week of pregnancy for 10 weeks.Then gestational diabetes is diagnosed by GGT in 24 - 28 week