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An RCT Study Between WHO and RCOG Based Practices

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07708090
Acronym
WHO and RCOG
Enrollment
100
Registered
2026-07-16
Start date
2026-09-01
Completion date
2026-12-20
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Anemia

Brief summary

Investigator is 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, investigator will compare these two methods to see which one is more helpful and suitable for mothers. Participants participation will help us improve care for women after childbirth in the future. Taking part is participants choice, and all participants information will be kept private.

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.

Interventions

DRUGIron 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.

Sponsors

Sana Nadeem Qasir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in postpartum hemoglobin levels /development of postpartum anemia6weekThe 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.

Countries

Pakistan

Contacts

CONTACTSana Nadeem Qasir, MBBs,trainee FCPS
nadeemsana77@gmail.com+923209801699
CONTACTProf.Dr.SARAH Jamil khan, consultant
PRINCIPAL_INVESTIGATORProf.Dr Sarah Jamil Khan, Consultant gynaecologist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026