An RCT Study Between WHO and RCOG Based Practices

NCT07708090 | Not Yet Recruiting

• 1 other identifier: 2026-15583
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Anemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ARM1 ,Intervention Arm,Intervention "Polymalt F(Iron Polymaltose Complex with folic acid)"

EXPERIMENTAL

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

Control Arm,No iron supplements drug Polymalt F (polymaltose complex with folic acid)given group

NO INTERVENTION

This group of postpartum women with normal hemoglobin levels will not receive iron supplements

Interventions

Iron Polymaltose Complex with folic acid DRUG

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.

Also known as: iron supplements

ARM1 ,Intervention Arm,Intervention "Polymalt F(Iron Polymaltose Complex with folic acid)"

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study will include postpartum women only. Participants will be females who have recently delivered and meet the eligibility criteria, including normal hemoglobin levels at enrollment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Sana Nadeem Qasir: lead

Study Sites (1)

Regional headquarters hospital chilas

Chilas, Gilgitbaltistan, 14100, Pakistan

Location

MeSH Terms

Interventions

teferrol; Folic Acid; Iron-Dextran Complex

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Prof.Dr Sarah Jamil Khan, Consultant gynaecologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sana Nadeem Qasir, MBBs,trainee FCPS

CONTACT

+923209801699; nadeemsana77@gmail.com

Prof.Dr.SARAH Jamil khan, consultant

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trainee FCPS Gynaecology and obstetrics

Model Details: Participants will be randomly assigned to one of two parallel groups. The intervention group will receive Polymalt F (iron polymaltose complex with folic acid), one tablet daily for 6 weeks postpartum, while the control group will receive standard postpartum care without routine iron supplementation. Outcomes will be compared between the two groups at 6 weeks postpartum.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

PA (1)