Effect of Oral Supplementation with micronized ferric pyrophosphate in pregnant women to prevent postpartum hemorrhage

Objective

The aim of this study was to evaluate the impact of oral supplementation with micronized ferric pyrophosphate in pregnant women to prevent postpartum hemorrhage

Methods

This was an observational retrospective study using data from clinical records of women with anemia who had visits at our private setting center. In this study, women who received oral supplementation with oral Sucrosomial Ferric Pyrophosphate plus Vitamin C, Folate, and Vitamin B12 daily as prophylactic treatment for iron deficiency anemia were compared with women who did not. The intervention group received the supplementation starting from the diagnosis of anemia until the day of delivery. The control group received standard care, i.e. ferrous sulphate (daily 80 mg Fe+2), starting from the diagnosis of anemia until the day of delivery.

Results

PPH occurred in 11/250 women in the intervention group and 19/250 in the control group (4.4% vs 7.6%; p value = non significant). Supplementation with Sucrosomial Ferric Pyrophosphate was associated with significantly higher ferritin level at the time of delivery, higher Hb level at the time of delivery and one month after delivery, and lower gastrointestinal side effects

Conclusion

Our study provides newer evidence that demonstrates the effectiveness of Sucrosomial iron, with fewer side effects, in pregnant women with mild anemia. Larger randomized trials are required to confirm our data. 

Keywords

infertility, supplement

Introduction

In pregnant women anemia is defined as hemoglobin (Hgb) level below 11 g/dL in the first trimester, or below 10.5 g/dL in the second trimester, or below 11 g/dL in the third trimester (1). Anemia may be acquired, such as deficiency anemia (e.g. iron, vitamin B12, folate), hemorrhagic anemia, anemia of chronic disease, aplastic anemia, or inherited, such as thalassemia, sickle cell anemia, or hemoglobinopathies other than sickle cell anemia.
Iron deficiency anemia is extremely common during pregnancy. It is an acquired anemia characterized by increased red blood cell production with mean corpuscular volume (MCV) less than 80 fL (microcytic anemia) (1). A national study of anemia in pregnancy found a prevalence of 22 per 1,000 pregnant women in the United States (2).
Oral iron supplementation is the gold standard approach for iron deficiency anemia in pregnancy (1). Different iron supplements are available on the market (3). They include ferrous fumarate, ferrous sulfate, ferrous gluconate, iron dextran, ferric gluconate, and iron sucrose (1,3). Sucrosomial Ferric Pyrophosphate (SunActive®Fe) has been associated with better tolerability and effectiveness compared to oral ferrous sulfate in several studies (4-6).
The aim of this study was to evaluate the impact of oral supplementation with micronized ferric pyrophosphate in pregnant women to prevent postpartum hemorrhage
 

Methods

This was an observational retrospective study using data from clinical records of women with anemia who had visits at our private setting center. Data were collected in a dedicated encrypted database and anonymized.  
In this study, women who received oral supplementation with oral Sucrosomial Ferric Pyrophosphate plus Vitamin C, Folate, and Vitamin B12 daily as prophylactic treatment for iron deficiency anemia were compared with women who did not. The intervention group received the supplementation starting from the diagnosis of anemia until the day of delivery. The control group received standard care, i.e. ferrous sulphate (daily 80 mg Fe+2), starting from the diagnosis of anemia until the day of delivery.
Inclusion criteria were singleton gestations with microcytic mild iron deficiency anemia. Mild anemia was defined as Hgb level between 9.00 and 10.99 g/dL. Exclusion criteria were multiple gestations, and moderate or severe anemia defined as Hgb level below 9.00 g/dL.
The primary outcome of the study was the incidence of postpartum hemorrhage (PPH). The secondary outcomes were rise in serum ferritin, rise in Hgb level and maternal tolerability.
Statistical analysis was performed using Statistical Package for Social Sciences (SPSS) v. 19.0 (IBM Inc., Armonk, NY, USA). Data were shown as means± standard deviation or as number (percentage). Dichotomous data were compared using the chi-square. Comparisons between groups were performed with the use of the T-test to test group means by assuming equal within-group variances. A sample size of 500 women was planned

Results

500 women were included in the study. 250 received the intervention, and 250 were included in a control group matched for demographics. No significant differences were found in baseline characteristics, shown in Table 1. The mean BMI was 23.4 in the intervention group, and 21.8 in the control group. 4 women in the intervention group had prior PPH in a prior pregnancy, and 7 in the control group.
Primary and secondary outcomes were show in Table 2. PPH occurred in 11/250 women in the intervention group and 19/250 in the control group (4.4% vs 7.6%; p value = non significant). Supplementation with Sucrosomial Ferric Pyrophosphate was associated with significantly higher ferritin level at the time of delivery, higher Hb level at the time of delivery and one month after delivery, and lower gastrointestinal side effects (Table 2).

Discussion

This study found that the use of Sucrosomial Ferric Pyrophosphate compared to standard ferrous sulphate, in pregnant women with mild anemia, is associated with increase hb level and trend for benefit in reduction of PPH.
Iron deficiency and iron anemia are highly prevalent and are the most common cause of anemia in pregnant women (7-11). Both iron deficiency and iron deficiency anemia represent significant health problems in pregnant women. Anemia may lead to prolonged length of stay in the hospital in the postpartum period, impaired quality of life, and depression. In addition it has other manifestations, including tiredness, and hair loss.
Gold standard treatment is oral iron supplementation, especially ferrous sulfate (12). However, it is associated with gastrointestinal side effects (13). Intravenous iron administration is more costly (14), and may cause hypersensitivity reactions (13).
Sucrosomial iron is an oral formulation consisting of ferric pyrophosphate conveyed by a phospholipid and sucrester matrix (sucrosome®) (16-18). These properties result in higher absorption and gastrointestinal tolerance. The absorption of sucrosomial iron is indeed mostly hepcidin-independent, and preliminary data suggested efficacy in treatment iron deficiency anemia (19).

Conclusion

Our study provides newer evidence that demonstrates the effectiveness of Sucrosomial iron, with fewer side effects, in pregnant women with mild anemia. Larger randomized trial are required to confirm our data.
 

REFERENCES
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	File/Dsecription
	Table-1 Maternal characteristics
	Table-2 Primary and secondary outcomes