Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Post Partum Iron Deficiency Anaemia
Comparative Analysis of Oral Iron With Injectable Ferric Carboxymaltose for Treatment of Post Partum Iron Deficiency Anaemia
The aim of this open label, interventional, randomized controlled clinical trial is to compare the efficacy and safety of ferric carboxymaltose injection with oral iron in treatment of postpartum iron deficiency anaemia in postnatal women. Inclusion criteria:women within 10 days of delivery, Hb >7 gm/dl and ≤10 gm and peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Primary outcome measures-rise in Hb from baseline to 4 and 6 weeks Secondary outcome measures-Percentage of patients achieving Hb >11 g/dl at 4 and 6 weeks.
Percentage of patients achieving Hb rise >3 g/dl from baseline at 4 and 6 weeks Change in red cell indices and peripheral smear from baseline to 6 weeks Side effects profile of injectable Ferric carboxymaltose injection and oral iron.
Researcher compares the efficacy and safety of ferric carboxymaltose with Oral iron in post partum iron deficiency anaemia Participant's detailed history, general physical and systemic examination was performed. CBC with red cell indices, reticulocyte counts, peripheral smear examination, serum Iron, Ferritin, Transferrin, TIBC levels and LFT were done.
Subjects were randomized in a 1:1 ratio into two groups: Group I (n=100) received intravenous ferric carboxymaltose and Group II (n=100) received oral ferrous Fumarate twice a day for 6 weeks.
All subjects were followed at 4 and 6 weeks. Repeat Hb estimation was done at 4 and 6 weeks while RBC indices and serum iron parameters were repeated at 6 weeks. Adverse effects were recorded.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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Delhi、インド、110015
- ESI-PGIMSR, Basaidarapur
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Postnatal women within 10 days of delivery.
- Hb should be >7 gm/dl and ≤10 gm.
- Peripheral smear showing microcytic hypochromic anaemia or red cell indices suggestive of iron deficiency anaemia or Mentzer index >13.
Exclusion Criteria:
- 1. Puerperal pyrexia. 2. Known drug allergy or intolerance to iron therapy. 3. History of chronic medical illness. 4. Known cases of Thalassemia 5. Received other intervention for management of anaemia such as blood transfusion in last three months.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Group I: Ferric carboxymaltose (FCM)
FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes During infusion, subject was kept under strict observation. FCM was repeated weekly up to calculated dose or maximum of 2500mg. Total dose of IV FCM was calculated by Ganzoni formula: - Total dose of iron = body weight (in kg) x (14-actual Hb) x 2.4 + 500 where, 14 is target Hb (g/dl), 2.4 unitless conversion constant, 500 is target iron store in mg |
FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes.
FCM was repeated weekly up to calculated dose or maximum of 2500mg.
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アクティブコンパレータ：Group II : Oral Iron
Second group of subjects were instructed to take oral iron (ferrous fumarate tablet containing 112 mg elemental iron) 2 times daily 1 hour before meals for 6 weeks.
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FCM was given as slow intravenous infusion; maximum single dose not exceeding 15 mg/kg or 1000 mg/dose in 250 ml of 0.9% normal saline over 15 minutes.
FCM was repeated weekly up to calculated dose or maximum of 2500mg.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II
時間枠：Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment
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The mean change in haemoglobin was measured at 4 weeks and 6 weeks post intervention in parenteral and oral group.
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Haemoglobin measurement at baseline, 4 week post treatment and 6 week post FCM intervention or adequate oral treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II
時間枠：Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment
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Percentage of women in the parenteral group as compared to oral group who achieved correction of anaemia i.e.
Hb >11gm/dl at 4 and 6 weeks post intervention.
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Anaemia correction (Hb>11gm/dl) at 4 week and 6 week post FCM intervention or adequate oral treatment
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Haemoglobin (Hb) rise> 3gm/dl from baseline at 4 and 6 weeks in group I versus Group II
時間枠：Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Women in the parenteral group as compared to oral group who achieved Haemoglobin rise of >3gm/dl at 4 and 6 weeks post intervention.
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Hb rise> 3 gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Haemoglobin (Hb) rise>2gm from baseline at 4 and 6 weeks in group I versus Group II
時間枠：Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Women in the parenteral group as compared to oral group who achieved haemoglobin (Hb) rise>2gm from baseline at 4 week and 6 week post intervention.
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Hb rise>2gm/dl at 4 week and 6 week post FCM intervention or adequate oral treatment
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Change in red cell indices and peripheral smear from baseline to 6 weeks
時間枠：Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment
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To record changes in all the haematological parameters from baseline to 6 weeks post intervention both parenteral and oral groups.
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Change in red cell indices and peripheral smear at baseline and 6 week post FCM intervention or adequate oral treatment
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Side effects profile for participants of Group I and II
時間枠：Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..
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To record the side effect profile in participants of parenteral and oral group in order to determine safety of the intervention upto 6 weeks post intervention.
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Side effects observed in participants receiving Group I and Group II treatment upto 6 weeks post intervention..
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Shreya Mahajan, MBBS、Post graduate resident, Department of OBG, ESI-PGIMSR, Basaidarapur,Delhi
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ESIPGIMSR-IEC/2024031
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国FDA規制医薬品の研究
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Ferric Carboxymaltose (FCM)の臨床試験
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