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

Not Applicable

Completed

• Conditions: Knowledge; Pregnant Women; Anemia
• Interventions: Other: Health Information Package Program (HIP program )

• Registration Number: NCT04661865
• Lead Sponsor: Jouf University

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.

Study Timeline

• Study First Submitted: 2020-11-28
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Study Start: 2021-01-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Health Information Package Program (HIP program )	Routine care only They will receive routine antenatal care that included iron supplementation with follow up of hemoglobin level
Intervention group	Health Information Package Program (HIP program )	They will receive the Heath Information Package Program (HIP program)

Primary Outcome Measures

Name	Time	Method
Haemoglobin	after three months ( 90 days ± 7 days)	\> 11 gm/ dl

Secondary Outcome Measures

Name	Time	Method
compliance with iron supplementation	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
knowledge	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

Trial Locations

Locations (1)

Primary Health Care centers; 🇸🇦 Jouf- Saudi Arabia, Jouf, Saudi Arabia