Clinical trial NCT04661865: Effect of Health Information Package Program on Knowledge and Compliance Among Pregnant Women With Anemia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge
Anemia
Pregnant Women
Keywords: Health Information Package
anemia
pregnant women
Lead sponsor: Jouf University
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: inclusion criteria

1. Aged between 18-45 years
2. Hemoglobin level less than11 gm/dl and hematocrit less than 30%
3. 14-20 pregnancy weeks
4. Singleton fetus
5. Have a smartphone with internet access (What's App) application
6. Able to read and write
7. Willing to give written informed consent to participate in the study.

Exclusion criteria:

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

Primary outcomes:
measure: Haemoglobin
timeFrame: after three months ( 90 days ± 7 days)
Secondary outcomes:
measure: knowledge
timeFrame: after three months ( 90 days ± 7 days) - study period
measure: compliance with iron supplementation
timeFrame: after three months ( 90 days ± 7 days)
Other outcomes:
Locations:
city: Jouf- Saudi Arabia
country: Saudi Arabia
facility: Primary Health Care centers
state: Jouf
Study officials:
References: