Effect of Health Information Package Program on Knowledge and Compliance Among Pregnant Women With Anemia

NCT04661865 | Completed

• 1 other identifier: DSR2020-04-3655
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Problem description: low compliance with iron supplementation of Saudi pregnant women with anemia is a serious public health concern. The objectives of the study are to determine the effectiveness of the Health Information Package Program (HIP program) in Saudi anemic pregnant women on their compliance with iron supplementation, and level of hemoglobin. Methodology: Randomized Controlled Trial will be conducted on 196 Saudi anemic pregnant women attending the Maternity and Children Hospital in Saudi Arabia their gestational age between 14 and less than 20 weeks. All participants will receive iron supplementation and they will learn how to take tablets. They will randomly assign to two intervention and control groups (98 each) using a computer-generated table of random numbers. The intervention group will receive a PowerPoint presentation of the Health Information Package Program (HIP program) that will be introduced by the principal investigator, combined with PowerPoint slides to educate women about anemia in pregnancy and send it to them via Whatsapp application while the control group will receive usual care. The participants will be informed about the nature and aim of the study with assuring confidentiality and anonymity. Expected outcome: Health Information Package Program (HIP program) will be effective in terms of increasing women's knowledge regarding anemia during pregnancy, increase compliance with iron supplementation, and hemoglobin level.

Conditions

Knowledge; Anemia; Pregnant Women

Keywords

Health Information Package; anemia; pregnant women

Outcome Measures

Primary Outcomes (1)

• Haemoglobin

  \> 11 gm/ dl

  after three months ( 90 days ± 7 days)

Secondary Outcomes (2)

• knowledge

  after three months ( 90 days ± 7 days) - study period

• compliance with iron supplementation

  after three months ( 90 days ± 7 days)

Study Arms (2)

Control group

OTHER

Routine care only They will receive routine antenatal care that included iron supplementation with follow up of hemoglobin level

Other: Health Information Package Program (HIP program )

Intervention group

EXPERIMENTAL

They will receive the Heath Information Package Program (HIP program)

Other: Health Information Package Program (HIP program )

Interventions

Health Information Package Program (HIP program ) OTHER

Fifteen minutes PowerPoint presentation will be introduced to women to increase women's educational experience and raise their level of engagement and commitment. The principal investigator will narrate the video record with PowerPoint slides and it was recorded as a video and will include information regarding the introduction to pregnancy, causes and predisposing factors of iron deficiency anemia during pregnancy, signs and symptoms, prevention, management of iron deficiency anemia during pregnancy that includes iron therapy, iron supplementation, dietary management. Content validity for the information in the video will be done by sending it to three experts in maternity nursing. Iron supplementation will be given to all participants who will start by sixteen weeks of pregnancy and they will receive information regarding the proper usage of iron supplements.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 1. Aged between 18-45 years 2. 14-20 pregnancy weeks 3. pregnant in singleton fetus
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18-45 years
• Hemoglobin level less than11 gm/dl and hematocrit less than 30%
• pregnancy weeks
• Singleton fetus
• Have a smartphone with internet access (What's App) application
• Able to read and write
• Willing to give written informed consent to participate in the study.

You may not qualify if:

• Cannot read and write,
• Have thalassemia or sickle cell anemia.
• Have a high-risk pregnancy.
• Had a history of psychiatric illness.
• Have already started iron supplementation for more than one week.

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

Primary Health Care centers

Jouf- Saudi Arabia, Jouf, 3677, Saudi Arabia

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The researchers will interview participants, explain the purpose of the study and they will ask them to sign the consent. All participants will receive iron supplementation and they will learn how to take tablets. They will randomly assign in two intervention and control groups (98 each) using a computer-generated table of random numbers and they are unaware of which group they have been assigned to as well as the outcome assessor is unaware
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Nursing, College of Applied Medical Sciences, Jouf University

Model Details: Group A: intervention group who will receive iron supplementation and Heath Information Package Program (HIP program) Group B: Control group: will receive iron supplementation and routine care

Study Record Dates

• First Submitted: November 28, 2020
• First Posted: December 10, 2020
• Study Start: January 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)