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Trial to study the effect of IV iron on post-pregnancy anemia to begin soon

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Dr Veena Aggarwal, Consultant Womens’ Health, CMD and Editor-in-Chief, IJCP Group & Medtalks Trustee, Dr KK’s Heart Care Foundation of India    14 November 2022

A trial to study the effect of intravenous iron for the treatment of anemia after pregnancy is expected to start in the new year. Intravenous iron supplementation has not been investigated as a treatment for post-pregnancy anemia, according to an NIH press release.1

The multicenter Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY; NCT05590260) randomized-controlled trial supported by the National Institutes of Health (NIH) will be conducted at 8 sites. A total of 4800 women in seven countries namely Bangladesh, Pakistan, Kenya, Zambia, the Democratic Republic of Congo, Guatemala and India will be recruited. A blood sample will be collected 6-48 hours after delivery to test for hemoglobin. Women with moderate anemia (Hb 7.0 to 9.9 g/dL) will be eligible for the study. Those who have received an iron infusion in the preceding 3 weeks or with known contraindications to iron supplementation will be excluded from the study.1,2

The study subjects will be randomized to either a single-dose IV iron infusion between 6 and 48 hours after childbirth before discharge or oral iron tablets taken twice daily for a period of 6 weeks. There would be two follow-up visits (at 6 weeks and 6 months) when they would be tested for hemoglobin, serum ferritin, serum transferrin receptor, C-reactive protein (CRP) and alpha 1 acid glycoprotein (AGP). A rapid diagnostic test (RDT) for malaria would also be done in malaria endemic countries. The study also has secondary endpoints - effects of postpartum depression on maternal quality of life, fatigue and breastfeeding initiation and retention rates. The study is likely to be completed by the end of 2025.

References

  1. NIH press release, November 10, 2022. Available at: https://www.nih.gov/news-events/news-releases/nih-funded-researchers-begin-study-intravenous-iron-treatment-post-pregnancy-anemia
  2. Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY). Available at: https://clinicaltrials.gov/ct2/show/NCT05590260.

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