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The effect of probiotic capsule on prevention of gestational diabetes

Phase 3
Recruiting
Conditions
Gestational Diabetes.
Diabetes mellitus arising in pregnancy
Registration Number
IRCT20180509039595N1
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
243
Inclusion Criteria

Willingness to participate;
Reading and writing literacy;
Earn Minimum 2 score of 20 score from the flowchart assess risk factors for gestational diabetes;
Have a phone number,
Being pre-diabetic,
The gestational age between 14 and 16 weeks based on the first day of the last menstruation or the first trimester ultrasound;
Normal screening tests for fetal abnormalities in the first stage;
Single pregnancy;
Fasting blood glucose less than 92 mg/dL and blood glucose two hours after food less than 120 mg/d

Exclusion Criteria

History of allergy to cow's milk
having a severe mental problem
having a stressful incidence in the last 3 months
smoking
Having intention to termination of pregnancy
Immune disorders
Having a medical condition
Pregnancy with in vitro fertilization
Taking antibiotics continuously over the past 3 months

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Frequency of abnormal OGTT in three groups of probiotic users, placebo and control group. Timepoint: After 70 days of intervention at the end of the study. Method of measurement: Perform an OGTT blood test.
Secondary Outcome Measures
NameTimeMethod
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