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.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Delhi, 인도, 110015
- ESI-PGIMSR, Basaidarapur
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean increase in haemoglobin at 4 weeks and 6 weeks in Group I versus Group II
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Anaemia correction(Hb >11 gm/dl), from baseline at 4 and 6 weeks in group I versus Group II
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Shreya Mahajan, MBBS, Post graduate resident, Department of OBG, ESI-PGIMSR, Basaidarapur,Delhi
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ESIPGIMSR-IEC/2024031
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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Ferric Carboxymaltose (FCM)에 대한 임상 시험
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Vifor PharmaICON Clinical Research; American Regent, Inc.완전한만성 신장 질환 | 철 결핍성 빈혈영국, 미국, 호주, 오스트리아, 벨기에, 체코 공화국, 덴마크, 프랑스, 독일, 그리스, 이탈리아, 네덜란드, 노르웨이, 폴란드, 포르투갈, 루마니아, 스페인, 스웨덴, 칠면조
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Vifor Pharma완전한
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Vifor PharmaICON Clinical Research완전한
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Biocruces Bizkaia Health Research InstituteSociedad Espanola de Angiologia y Cirugia Vascular모병