NCT07800611

Brief Summary

Anemia is a major public health problem among pregnant women, particularly in low- and middle-income countries. It is characterized by a reduction in hemoglobin concentration or the oxygen-carrying capacity of the blood, which may be insufficient to meet the physiological needs of the body. Maternal anemia is associated with an increased risk of adverse maternal and fetal outcomes. Despite the high prevalence of anemia among pregnant women, poor medication adherence and inadequate understanding of prescribed therapy may limit treatment effectiveness. Pharmacists can play an important role in providing medication-related education, improving patients' understanding of their treatment, identifying barriers to adherence, and promoting appropriate medication use. However, evidence on pharmacist-led educational interventions to improve medication adherence and hemoglobin levels among anemic pregnant women in Pakistan remains limited. Therefore, this randomized controlled trial will be conducted to evaluate the effect of a structured pharmacist-led educational intervention on medication adherence and hemoglobin levels among anemic pregnant women in District Chakwal, Punjab, Pakistan. A total of 100 eligible pregnant women diagnosed with anemia will be recruited and randomly allocated into intervention and control groups. Participants in the intervention group will receive a structured pharmacist-led educational intervention in addition to routine care, while participants in the control group will receive routine antenatal care and standard anemia management. Medication adherence and hemoglobin levels will be assessed at baseline and after the intervention. The study will determine whether pharmacist-led educational counseling improves medication adherence and hemoglobin levels compared with routine care. Data will be analyzed using IBM SPSS Statistics version 26. A paired-sample t-test will be used to compare changes in continuous variables, particularly hemoglobin levels, between baseline and post-intervention assessments. McNemar's test will be used to assess changes in paired categorical variables, including medication adherence where appropriate. A p-value of \<0.05 will be considered statistically significant.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

August 18, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 18, 2026

Last Update Submit

August 30, 2026

Conditions

Keywords

AnemiaPharmacistintervention

Outcome Measures

Primary Outcomes (3)

  • Change in hemoglobin concentration

    Description: Change in hemoglobin (Hb) concentration from baseline to one-month follow-up, measured in g/dL using a laboratory hemoglobin test.

    Baseline and one month after the pharmacist-led counseling intervention.

  • Change in anemia severity

    Description: Change in anemia severity from baseline to one-month follow-up, categorized according to the participant's measured hemoglobin concentration using the predefined diagnostic criteria for anemia.

    Baseline and one month after the pharmacist-led counseling intervention.

  • Medication adherence

    Description: Change in medication adherence from baseline to one-month follow-up, assessed using the \[name of your actual validated adherence scale/questionnaire\].

    Time Frame: Baseline and one month after the intervention.

Study Arms (1)

Pre and post evaluation

OTHER

Pharmacist-Led Anemia Counseling: Patients will receive individualized pharmacist-led counseling regarding anemia management, medication adherence, appropriate use of prescribed medicines, dietary measures, and strategies to improve quality of life. Outcomes will be assessed before the intervention and at one-month follow-up. Study Design: Single-arm, pre-post evaluation.

Other: Pharmacist-led counseling on anemia management

Interventions

Intervention Description: Patients will receive individualized pharmacist-led counseling regarding anemia management, medication adherence, appropriate use of prescribed medicines, dietary measures, and strategies to improve quality of life. Outcomes will be assessed before the intervention and at one-month follow-up. Study Design: Single-arm, pre-post evaluation.

Also known as: Pharmacist-Led Anemia Counseling
Pre and post evaluation

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Details1. Pregnant woman 2. Hb \<11g/dl
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant woman
  • Hb \<11g/dl
  • Having Punjab domicile-

You may not qualify if:

  • Patients with co-morbidities
  • Patients with Hb \>11g/dl
  • Outside the Punjab domicile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Chakwal

Islamabad, Islamabad, 45570, Pakistan

Location

Related Publications (1)

  • Adje, D., et al. (2020). "Impact of pharmacists' health educational intervention on anemia in pregnancy in rural settings in Kano, Nigeria." Int. J. Pharm. Sci. Res 11: 2403-2410.

    RESULT

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 18, 2026

First Posted

September 2, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

September 2, 2026

Record last verified: 2026-08

Locations