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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sana Nadeem Qasir, MBBs,trainee FCPS | Contact | +923209801699 | +925812920063 | nadeemsana77@gmail.com |
| Prof.Dr.SARAH Jamil khan, consultant | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Prof.Dr Sarah Jamil Khan, Consultant gynaecologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional headquarters hospital chilas | Chilas | Gilgitbaltistan | 14100 | Pakistan |
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| ID | Term |
|---|---|
| C013276 | teferrol |
| D005492 | Folic Acid |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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.
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|
|
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |