Postpartum AnemiaWHO and RCOGNCT07708090
An RCT Study Between WHO and RCOG Based Practices
A study testing Iron Polymaltose Complex with folic acid in people with Postpartum Anemia, run by Sana Nadeem Qasir at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Anemia
- What is being tested?
- Iron Polymaltose Complex with folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years
- Single Term Vaginal delivery
- Hemoglobin ≥10.5 g/dL at 24hour of delivery
- Willing for follow-up
Who cannot join
- Postpartum hemorrhage
- Hemoglobin <10.5 g/dL
- Blood transfusion received
- Known hematological disease
- Chronic liver or kidney disease
- Cesarian section
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Prof.Dr.SARAH Jamil khan, consultant contact
Pakistan1 site
Regional headquarters hospital chilas
Chilas, Gilgitbaltistan, 14100
About this study
Official title: A Randomized Controlled Trial Comparing WHO- and RCOG-Based Practices for Routine Iron Supplementation in Postpartum Women With Normal Hemoglobin Level
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.
Read the 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.
- Conditions
- Postpartum Anemia
- Being tested
- Iron Polymaltose Complex with folic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Polymaltose Complex with folic acidDrug
Also called iron supplements
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana Nadeem Qasir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sana Nadeem Qasir, RHQ Hospital, Chilas, Pakistan
- Investigators
- Prof.Dr Sarah Jamil Khan, Consultant gynaecologist, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708090
- Sponsor's protocol ID
- 2026-15583
- Acronym
- WHO and RCOG
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing WHO- and RCOG-Based Practices for Routine Iron Supplementation in Postpartum Women With Normal Hemoglobin Level
- ClinicalTrials.gov ID
- NCT07708090
- Acronym / sponsor ID
- WHO and RCOG / 2026-15583
- Conditions
- Postpartum Anemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sana Nadeem QasirUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARM1 ,Intervention Arm,Intervention "Polymalt F(Iron Polymaltose Complex with folic acid)" | Experimental | Drug: Iron Polymaltose Complex with folic acidPostpartum 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-40 years
- Single Term Vaginal delivery
- Hemoglobin ≥10.5 g/dL at 24hour of delivery
- Willing for follow-up
Key exclusion criteria (6 listed)
- Postpartum hemorrhage
- Hemoglobin <10.5 g/dL
- Blood transfusion received
- Known hematological disease
- Chronic liver or kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Polymaltose Complex with folic acidAlso: iron supplementsParticipants 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. | Drug | ARM1 ,Intervention Arm,Intervention "Polymalt F(Iron Polymaltose Complex with folic acid)" |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof.Dr.SARAH Jamil khan, consultant contact
Prof.Dr Sarah Jamil Khan, Consultant gynaecologist principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Polymaltose Complex with folic acid in people with Postpartum Anemia, run by Sana Nadeem Qasir at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sana Nadeem Qasir, MBBs,trainee FCPS (+923209801699 ext. +925812920063, nadeemsana77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postpartum hemoglobin levels /development of postpartum anemia (time frame: 6week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.