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临床试验/NCT04661865
NCT04661865已完成不适用

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

Jouf University2 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
196
试验地点
2
主要终点
Haemoglobin

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Haemoglobin

时间窗: after three months ( 90 days ± 7 days)

\> 11 gm/ dl

次要结局

  • compliance with iron supplementation(after three months ( 90 days ± 7 days))
  • knowledge(after three months ( 90 days ± 7 days) - study period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadia Elsharkawy

Associate Professor - Department of Nursing, College of Applied Medical Sciences, Jouf University

Jouf University

研究点 (2)

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