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Completed

NCT Number: NCT04661865

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

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.

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Key information

Conditions

Knowledge Anemia Hematologic Diseases Hemic and Lymphatic Diseases Pregnant Women

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health Care centers

Jouf- Saudi Arabia, Jouf, 3677, Saudi Arabia

About this study

The present study aims to assess the efficacy of the Health information package program (HIP program) on compliance with iron supplementation pills, and the level of hemoglobin among Saudi pregnant women with anemia.

The study will be conducted in antenatal outpatient clinics at primary health care centers.

Data Collection tools

I- Demographic and health-related information included data related to women's age, marriage age, level of education, gestational age, parity, body mass index, inter-pregnancy interval, history of excessive or abnormal bleeding during menstruation, and level of hemoglobin.

II- compliance with iron supplementation included questions related to the extent of compliance with iron supplementation among anemic pregnant women and the reason for compliance or non-compliance.

III- The food selection ability checklist contained food items that are rich and poor sources of iron, vitamin C, and protein.

IV- Structured Knowledge Interview Schedule (SKIS): This tool was developed to assess women information before and after the intervention, it contained questions regarding the concept of pregnancy, anemia in pregnancy, causes of iron deficiency anemia, signs and symptoms, the effect of anemia on pregnancy, prevention, and management of iron deficiency anemia. Each correct answer is assigned one point. The maximum number of total possible points was 86.

Random assignment will use to classify the participants equally (98 women each) either in the intervention or control groups using a computer-generated table of random numbers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18-45 years
  • Hemoglobin level less than11 gm/dl and hematocrit less than 30%
  • 14-20 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Haemoglobin

    Time frame: after three months ( 90 days ± 7 days)

    > 11 gm/ dl

Secondary outcomes

  1. knowledge

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

    The overall number of knowledge related questions is 86 High knowledge: 57-71 Moderate knowledge: 36- 56 tablets Low knowledge: <36 tablets

  2. compliance with iron supplementation

    Time frame: after three months ( 90 days ± 7 days)

    The overall number of iron tablets that should have been taken during the three month study period will be 90

    High compliance: 68-90 tablets Moderate compliance: 45- 67 tablets Low compliance: <45 tablets

Sponsors and collaborators

Lead sponsor

Jouf University

Other

Registry information

Official study title

Effect of Health Information Package Program (HIP Program) on Knowledge, Compliance , and Hemoglobin Level Among Saudi Pregnant Women With Anemia: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 10, 2020
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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