Comparison of prevalence of sleep disorders in third trimester pregnant in groups 1 and 2after intervention
Design
A randomized controlled clinical trial with double blinded parallel groups(Blocking) design of 100 people
Settings and conduct
This study is a double-blind clinical trial. The study population consisted of all pregnant women who were referred to Sabzevar health centers during the weeks 32-32 of pregnancy. After obtaining permission from the Ethics Committee of Sabzevar University of Medical Sciences and obtaining written consent, 100 mothers were asked to complete the Sleep Quality Index Questionnaire in Sabzevar Vasie Hospital.
Participants/Inclusion and exclusion criteria
Enter:Women between the ages of 28 and 32 weeks gaining a score of 5 and higher in the Pittsburgh questionnaire and women's willingness to participate in the study.
Exit: Existence of underlying disease, having a speacial diet and taking supplemants other than supplemants pregnancy, narcotic products using
Intervention groups
Intervention group Vitamin B6 80 mg single dose per night (based on midwifery reference books, the maximum allowed dose is 1.9 mg / kg body weight, and therapeutic efficacy of up to 3 dosed of 40 mg has been used in the literature). The control group received a placebo made by a factory of shape, color, taste and convexity similar to the intervention group, and the mothers were instructed to consume 2 pills each night.
Main outcome variables
Third trimester sleep disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190718044257N1
Registration date:2020-08-21, 1399/05/31
Registration timing:retrospective
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Zahra Iziy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4413 4154
Email address
zborooghani1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-01, 1398/10/11
Expected recruitment end date
2020-07-01, 1399/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin B6 consumption in comparison with placebo on sleep disorder in the third trimester of pregnancy in pregnant women
Public title
effect of vitamin B6 on sleep in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with gestational age of 28-32weeks
Get a score of 5 or higher on the Pittsburgh questionnaire
Women's willingness to participate an the study
No history of sleep disorders before pregnancy
Ladies working without night shift
Female 18 to 35 years
No history of infertility
Exclusion criteria:
Existence of mom's underlying disease
Taking sleeping pills
History of pre_pregnancy sleep disorders
Know complication of pregnancy
Narcotic products using
Having a speacial diet
Get a score of 40 or higher on the Spielberger questionnaire
Working lady with night working hours
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified sampling: For sampling, each person will be selected for inclusion in the study, and then the samples will be divided into two intervention groups (A(or control)B) based on 4_block design and random allocation. A 4_block will be used for sampling (AABB, ABAB, BBAA, BABA)
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was administered to the intervention group and the placebo control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Sleep Quality Score in Pittsburgh Sleep Quality Questionnaire
Timepoint
Before intervention-One week after intervention
Method of measurement
Pittsburgh Sleep Quality Index Questionnaire
Secondary outcomes
1
Description
mprove sleep disorders of pregnant women
Timepoint
Third trimester of pregnancy
Method of measurement
Completing the questionnaire
Intervention groups
1
Description
Intervention group: A group that consumes 80 mg of vitamin B6 per night in a single dose for a week, so that mothers are taught to take 2 pills every night befor bed, one week after the intervention, the mothers are contacted for a visit.
Category
Treatment - Drugs
2
Description
Control group: The group that takes placebo(made by a factory with the same shape, size, color, taste, convexity and logo as the intervention group) for a week, and mothers are taught to take 2 pills every night befor bed, and will be visited the next week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialty Perinatology Clinic of Vasei Hospital, Sabzevar, Iran