Real-world evaluation of safety and effectiveness of ferrous bis-glycinate and its combination in pregnant women with iron deficiency anemia

Anagha Pradyumna Pai Raiturker; Geeta  Ponnuswami; Jalpa H. Shah; Seema Rajesh Patil; Jyotsna P. Daule; Monika Chinda; Ashok Jaiswal

doi:10.18203/2320-1770.ijrcog20231201

Authors

Anagha Pradyumna Pai Raiturker Department of Obstetrician and Gynaecologist, Siddhatek Apts, Prabhat Roads, Near Punjab National Bank, Pune, Maharashtra, India
Geeta Ponnuswami Department of Obstetrician and Gynaecologist, Government Kipauk Medical College, Chennai, Tamil Nadu, India
Jalpa H. Shah Department of Obstetrician and Gynaecologist, Shree Nath Hospital, Modasa, Gujarat, India
Seema Rajesh Patil Department of Obstetrician and Gynaecologist, Vishwa Prabha Hospital, Akashwani Chowk, Jalgaon, Maharashtra, India
Jyotsna P. Daule Department of Obstetrician and Gynaecologist, Daule Hospital, Nagar -Manmad Road, Savedi, Ahmednagar-414003, India
Monika Chinda Department of Medical Affairs, Zydus Lifesciences Ltd, Near Fern Hotel, Goregaon East, Mumbai, Maharashtra, India
Ashok Jaiswal Department of Medical Affairs, Zydus Lifesciences Ltd, Near Fern Hotel, Goregaon East, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20231201

Keywords:

Iron deficiency anemia, Ferrous bisglycinate, Pregnancy, Hemoglobin

Abstract

Background: Iron deficiency is the most common cause of anemia during pregnancy. It leads to adverse outcomes on maternal and infant morbidity/mortality. There is a reduction in hemoglobin levels due to an increase in iron demand during pregnancy. Many pregnant women have poor or depleted iron stores and the amount of iron from the diet together with mobilized stores from the body is insufficient to meet the maternal demands. To meet iron demands, regular iron supplementation is recommended. Conventional iron supplements report frequent gastrointestinal side effects. Therefore, this study aimed to evaluate the safety, effectiveness, tolerability, and compliance of ferrous bis-glycinate and it’s combination for treating iron deficiency anemia during pregnancy.

Methods: This was a retrospective analysis of data collected from 34 obstetricians and gynecologists across India, on the use of ferrous bis-glycinate and it’s combination as iron supplementation to pregnant women. The clinical records were analyzed for the objective i.e., rise in hemoglobin, safety, tolerability, and compliance.

Results: 374 completed case records forms were considered for the analysis. These pregnant women had taken supplementation with ferrous bis-glycinate and its combination for an average of 58.5 days. The use of ferrous bis-glycinate and it’s combination improved mean hemoglobin concentration from 8.86 gm/dL to 11.27 gm/dL. With respect to safety, 97.6% of pregnant women did not report any adverse events. The remaining 2.4% had mild gastrointestinal side effects. Furthermore, 93% of pregnant women rated the tolerability as very good to good, and >98% of patients complied with >80% of treatment with ferrous bis-glycinate.

Conclusions: This retrospective analysis suggests that ferrous bis-glycinate and it’s combination as iron supplementation in pregnancy is safe, effective, and well-tolerated.

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