A Randomized Controlled Trial Comparing WHO- and RCOG-Based Practices for Routine Iron Supplementation in Postpartum Women With Normal Hemoglobin Level
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in postpartum hemoglobin levels /development of postpartum anemia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
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
Intervention: Iron Polymaltose Complex with folic acid (Drug)
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
Outcomes
Primary Outcomes
Change in postpartum hemoglobin levels /development of postpartum anemia
Time Frame: 6week
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sana Nadeem Qasir
Trainee FCPS Gynaecology and obstetrics
RHQ Hospital, Chilas, Pakistan