Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anemia
  • Knowledge
  • Pregnant Women
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Group A: intervention group who will receive iron supplementation and Heath Information Package Program (HIPP) Group B: Control group: will receive iron supplementation and routine careMasking: Double (Participant, Outcomes Assessor)Masking Description: 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 unawarePrimary Purpose: Other

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Description

The present study aims to assess the efficacy of the Health information package program (HIPP) on knowledge about anemia, compliance with iron supplementation pills, and level of hemoglobin among Saudi pregnant women with anemia. The present sample will be calculated using G-power analysis version 3...

The present study aims to assess the efficacy of the Health information package program (HIPP) on knowledge about anemia, compliance with iron supplementation pills, and level of hemoglobin among Saudi pregnant women with anemia. The present sample will be calculated using G-power analysis version 3.1.1, where the Power of .95 (?=1-0.95=0.5) at alpha 0.05 (one-sided) was used as the significance level, and medium effect size = (0.5) was utilized. The required sample will be 178 anemic pregnant women; this number will be increased to reach 196 for an expected attrition rate of 10%. 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. The study will be conducted in antenatal outpatient clinics at primary health care centers, Sakakah- Al-Jouf region in the northwest part of the Kingdom of Saudi Arabia. The hospital is affiliated with the Ministry of Health and provides free-of-charge health care services for all pregnant women, neonates, and children. Nearly 4700 women visited the antenatal clinic through the period of 2019. Data Collection tools A structured interview questionnaire will be used to fulfill the study objectives. Study tool developed by Noronha et al. (2013) and translated to simple Arabic language that is appropriate to Arabian Culture by Abujilban et al. (2018). Permission and acceptance to use the Arabic version of the tool were maintained by Abujilban. The tool has internal reliability for the Arabic version with Cronbach alpha = 0.938. 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 knowledge about anemia 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 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.

Tracking Information

NCT #
NCT04661865
Collaborators
Not Provided
Investigators
Not Provided