Protocol summary
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Study aim
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The impact of Myo-inositol supplementation with sleep hygiene education on sleep quality in pregnant women
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Design
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In this study, 60 pregnant women with a gestational age of at least 14 weeks who are referred to the Obstetric and Gynecology Clinics of Babol are selected. The participants were divided With a block size of 4, into two groups of A and B (intervention and control) by selecting the number of (0 - 6) are randomly assigned using computer software.
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Settings and conduct
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In this study, the participants, in case of severe depression and severe stress according to the Beck Depression Inventory and Perceived Stress Scale questionnaire are excluded. The subjects in both groups were asked to complete a demographic questionnaire, sleep quality, and sleep Hygiene index and then is given sleep hygiene education. Women were randomly divided into two groups, in group 1 (n=30) ), people treated with myoinositol supplementation powder and the control group ( n=30 ) received placebo for a total of 10 weeks. Evaluation (replenishment of the sleep hygiene questionnaire, sleep quality questionnaire) and determining the side effects of the drug in the second trimester in weeks (24-28) and evaluation in the third trimester in the weeks (37-38).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: gestational age of 14 weeks; absence of chronic diseases; no history of sleep disorders before pregnancy; no history of abortion in previous pregnancies.
Exclusion criteria: severe depression or severe stress; death experience of one of the first-degree relatives during pregnancy, and changes in sleep status due to travel.
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Intervention groups
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Interventions group: myoinositol supplementation powder (myoinositol + folic acid)
Control group: placebo (folic acid + wheat flour)
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Main outcome variables
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Sleep quality; neonatal and pregnancy outcomes and side effect of drug
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160208026446N3
Registration date:
2018-06-03, 1397/03/13
Registration timing:
registered_while_recruiting
Last update:
2019-08-29, 1398/06/07
Update count:
1
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Registration date
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2018-06-03, 1397/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-04-07, 1397/01/18
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Expected recruitment end date
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2019-02-19, 1397/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The impact of Myo-inositol supplementation with sleep hygiene education on sleep quality in pregnant women
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Public title
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The impact of Myo-inositol supplementation with sleep hygiene education on sleep quality in pregnant women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Conscious written consent
Pregnant women with singletone pregnancy
Age 18 and over
Gestational age of 14 weeks
Absence of chronic physical diseases such as diabetes, high blood pressure and cardiovascular disease
No history of taking prenatal drugs before pregnancy
No history of sleep disorders before pregnancy
Working women without night shift work
Non-smoking and alcohol
Lack of history of psychiatric use
No history of abortion in previous pregnancies
Exclusion criteria:
Severe depression or severe stress
Death experience of one of the first-degree relatives during pregnancy
Changes in sleep status due to travel
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Blocked randomization with a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blind groups include: participant, clinical caregiver, researcher, outcome evaluator, data analyst. Double blind study.
Medications and placebo are coded by someone other than the investigator as group (1 and 2) and the investigator do not know which group is related to the drug.
The subjects are satisfied and informed that they may be Instead of medication, placebo is given to them. The distribution method With a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-19, 1397/02/29
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Ethics committee reference number
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IR.MUBABOL.HRI.REC.1397.032
Health conditions studied
1
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Description of health condition studied
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Sleep quality in pregnancy
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ICD-10 code
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G47
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ICD-10 code description
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Sleep disorders
Primary outcomes
1
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Description
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Sleep Quality Score in Pittsburgh Sleep Quality Questionnaire
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Timepoint
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In the second trimester of pregnancy at weeks 24 to 28 and in the third trimester of pregnancy at weeks 37 to 38 of pregnancy.
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Method of measurement
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Pittsburgh Sleep Quality Index Questionnaire
Secondary outcomes
1
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Description
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Neonatal and pregnancy outcomes
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Timepoint
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The end of pregnancy for the outcome of pregnancy and infancy Method of measurement
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Method of measurement
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Questionnaire and complete the checklist using file.
2
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Description
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Side effect of drug
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Timepoint
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In the second trimester of pregnancy (week 24-28) and the third trimester of pregnancy (week 37_38)
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Method of measurement
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Drug side effect checklist
Intervention groups
1
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Description
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Intervention group: myoinositol supplementation powder the ino folic commercial name containing 2000 mg of myoinositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day (one sachet per night in a glass of water is dissolved) from gestational age 14 to 24 weeks)
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Category
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Prevention
2
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Description
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Control group: placebo (folic acid powder 400 mcg + wheat flour total 2 grams) Once a day (one hour a sachet is dissolved in a glass of water) from the gestational age 14 weeks to 24 weeks for a total of 10 weeks .
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable