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Trial registered on ANZCTR


Registration number
ACTRN12616001424493
Ethics application status
Approved
Date submitted
14/06/2016
Date registered
12/10/2016
Date last updated
12/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of a planned Health Education Program On the compliance and knowledge of Jordanian Pregnant Women with anemia
Scientific title
The Effect of an intervention Health Education Program On Jordanian Anemic Pregnant Women’s Knowledge, Compliance and Hemoglobin Level": Evidence from RCT with a public maternity hospital in Irbid, North of Jordan

Secondary ID [1] 289458 0
None
Universal Trial Number (UTN)
U1111-1184-2882
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anemia during pregnancy 300494 0
Condition category
Condition code
Reproductive Health and Childbirth 300353 300353 0 0
Fetal medicine and complications of pregnancy
Blood 300354 300354 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The written draft of structured educational program about anemia during pregnancy was converted to a single video for 15- minutes duration. The information in the video record will be given by the voice of Specialist midwife in combination of PowerPoint slides
The areas covered in the video records were: Introduction to pregnancy and anemia of pregnancy, causes and predisposing factors of iron deficiency anemia in pregnancy, the effect of anemia in pregnancy, signs, and symptoms, management of iron deficiency anemia, which includes iron therapy, dietary management, and prevention of anemia.
The video and its content were validated by specialists in the field of obstetric health nursing.
The intervention will be given as video record to participants in the experimental group
from the researcher via a WhatsApp application on their smartphones, to make sure that the participant will adhere to the intervention and all of them will watch the video, WhatsApp application will show two blue check marks next to send messages, that indicate the recipient has read the message or seen the video.
Intervention code [1] 296062 0
Treatment: Devices
Intervention code [2] 296063 0
Behaviour
Comparator / control treatment
The control group will receive standard care in antenatal clinics which is iron supplementation for all pregnant women from the beginning of the second trimester but,will not receive the intervention which is educational program about anemia during pregnancy
Control group
Active

Outcomes
Primary outcome [1] 299810 0
Level of knowledge assessed using a questionnaire designed for this study will be increased after the health education program as evidenced by post-test total score of knowledge questionnaire
Timepoint [1] 299810 0
after watching the educational video through Whatsapp application
Secondary outcome [1] 328186 0
Haemoglobin level will be increased after health educational program as evidenced by Haemoglobin level, assessed by serum assay
Timepoint [1] 328186 0
within four weeks after the intervention

Eligibility
Key inclusion criteria
Pregnant women with anemia aged between 18-45 years in their second trimester of pregnancy, and their hemoglobin levels below 10.5 mg/dl,have smart phones with an access to social media (Whatsapp application) will be included in the study.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women who are illiterate or have a history of obstetric, medical or psychological problems

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
two group experimental will receive the educational program (intervention) while control group will receive usual care with no education
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7955 0
Jordan
State/province [1] 7955 0
irbid city

Funding & Sponsors
Funding source category [1] 293817 0
University
Name [1] 293817 0
Jordan university of science and technology (JUST)
Address [1] 293817 0
Jordan University of Science and Technology
P.O.Box 3030, Irbid 22110, Jordan
Country [1] 293817 0
Jordan
Primary sponsor type
University
Name
JUST university
Address
Jordan University of Science and Technology
P.O.Box 3030, Irbid 22110, Jordan
Country
Jordan
Secondary sponsor category [1] 293498 0
None
Name [1] 293498 0
Address [1] 293498 0
Country [1] 293498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295249 0
Institutional Review Board of Jordan University of Science and Technology
Ethics committee address [1] 295249 0
Jordan University of Science and Technology
P.O.Box 63001, Irbid 22110, Jordan
Ethics committee country [1] 295249 0
Jordan
Date submitted for ethics approval [1] 295249 0
03/12/2015
Approval date [1] 295249 0
06/02/2016
Ethics approval number [1] 295249 0
234/2016

Summary
Brief summary
This study aimed to determine the effectiveness of a health information package in terms of empowering the pregnant women to modify their health care behavior and take appropriate action to combat anemia in pregnancy.
This aim was achieved through the following:
Assessing knowledge and knowledge related practices of pregnant women regarding iron deficiency anemia.
Adopt and implement health information package program for pregnant women with IDA regarding knowledge of IDA risk factors, iron rich foods and the importance of intake of iron supplementation and their practice toward iron intake.
Evaluating the effect of health information package program on the compliance, knowledge and hemoglobin level among anemic pregnant women.
we hypothesized that Jordanian pregnant women who receive health information package program will experience a higher level of knowledge, compliance and a higher hemoglobin level than those who will not receive the planned health educational program

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66542 0
Ms sahar mohammed shuqera
Address 66542 0
Maternal and Child Health and Midwifery Department
Jordan university of Science and Technology/ Faculty of Nursing
mail address: P.O Box 3030 Irbid 22110, Jordan
Country 66542 0
Jordan
Phone 66542 0
+962775390290
Fax 66542 0
Email 66542 0
sm_shs14@yahoo.com
Contact person for public queries
Name 66543 0
A/Prof Reem Hatamleh
Address 66543 0
Maternal and Child Health and Midwifery Department
Jordan university of Science and Technology/ Faculty of Nursing
mail address: P.O Box 3030 Irbid 22110, Jordan


Country 66543 0
Jordan
Phone 66543 0
+96227201000 Ext, 23712
Fax 66543 0
Email 66543 0
reem1969@yahoo.com
Contact person for scientific queries
Name 66544 0
A/Prof Reem Hatamleh
Address 66544 0
Maternal and Child Health and Midwifery Department
Jordan university of Science and Technology/ Faculty of Nursing
mail address: P.O Box 3030 Irbid 22110, Jordan
Country 66544 0
Jordan
Phone 66544 0
+96227201000 Ext, 23712
Fax 66544 0
Email 66544 0
reem1969@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary