An RCT Study Between WHO and RCOG Based Practices (WHO and RCOG)

A Randomized Controlled Trial Comparing WHO- and RCOG-Based Practices for Routine Iron Supplementation in Postpartum Women With Normal Hemoglobin Level

We are doing this study to understand the best way to give iron supplements to mothers after delivery who already have a normal blood level (hemoglobin). Some guidelines recommend one approach, while others recommend a different approach. In this study, we will compare these two methods to see which one is more helpful and suitable for mothers. Your participation will help us improve care for women after childbirth in the future. Taking part is your choice, and all your information will be kept private.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Anemia
• Intervention / Treatment: Drug: Iron Polymaltose Complex with folic acid

Detailed Description

Postpartum women may be at risk of developing iron deficiency and postpartum anemia due to blood loss during childbirth. Iron supplementation after delivery is commonly used to prevent anemia; however, the benefit of routine iron supplementation in postpartum women who already have normal hemoglobin levels remains an area of discussion.

This randomized controlled trial aims to compare routine iron supplementation with no iron supplementation in postpartum women with normal hemoglobin levels.

Eligible postpartum women with normal hemoglobin levels will be randomly allocated into two groups. The intervention group will receive Polymalt F (iron polymaltose complex with folic acid), one tablet daily for 6 weeks postpartum. The control group will not receive routine iron supplementation during the study period and will receive standard postpartum care.

Participants will be followed up at 6 weeks postpartum. Maternal outcomes will be assessed, including hemoglobin level, development of postpartum anemia, fatigue level,compliance with supplementation, and any reported side effects among participants receiving iron.

The primary outcome of this study is to determine whether routine iron supplementation prevents postpartum anemia in women with normal hemoglobin levels. The findings may help provide evidence regarding the need for routine iron supplementation after childbirth and improve postpartum care practices.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sana Nadeem Qasir, MBBs,trainee FCPS; Phone Number: +925812920063 +923209801699; Email: nadeemsana77@gmail.com
• Study Contact Backup: Name: Prof.Dr.SARAH Jamil khan, consultant

Study Locations

• Pakistan
  • Gilgitbaltistan
    • Chilas, Gilgitbaltistan, Pakistan, 14100
      • Regional headquarters hospital chilas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Women aged 18-40 years Single Term Vaginal delivery Hemoglobin ≥10.5 g/dL at 24hour of delivery Willing for follow-up

Exclusion Criteria:

Postpartum hemorrhage Hemoglobin <10.5 g/dL Blood transfusion received Known hematological disease Chronic liver or kidney disease Cesarian section

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM1 ,Intervention Arm,Intervention "Polymalt F(Iron Polymaltose Complex with folic acid)"; Postpartum women with normal hemoglobin levels who will receive intervention with iron supplements" Polymalt F (Iron Polymaltose Complex with folic acid)"1 daily orally for 6 week	Drug: Iron Polymaltose Complex with folic acid; Participants in the intervention group will receive drug Polymalt F (iron polymaltose complex with folic acid), one tablet orally once daily for 6 weeks after delivery. The purpose of this intervention is to evaluate whether routine iron supplementation helps prevent postpartum anemia in women with normal hemoglobin levels.; Other Names: iron supplements
No Intervention: Control Arm,No iron supplements drug Polymalt F (polymaltose complex with folic acid)given group; This group of postpartum women with normal hemoglobin levels will not receive iron supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postpartum hemoglobin levels /development of postpartum anemia	The primary outcome is to assess the effectiveness of routine iron supplementation in preventing postpartum anemia among women with normal hemoglobin levels. Hemoglobin levels will be measured at 6 weeks postpartum and compared between the iron supplementation group and the no iron supplementation group.	6week

Collaborators and Investigators

• Sponsor: Sana Nadeem Qasir
• Investigators: Principal Investigator: Prof.Dr Sarah Jamil Khan, Consultant gynaecologist

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Coordination Complexes; Pterins; Pteridines; Polysaccharides; Glucans; Dextrans; Folic Acid; Iron-Dextran Complex; teferrol
• Other Study ID Numbers: 2026-15583

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No