Well Being of Obstetric Patients on Minimal Blood Transfusions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Physical Fatigue
研究概览
简要总结
Postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in developed and developing countries. The most important treatment of PPH is red blood cell (RBC) transfusion. The decision whether to prescribe RBC transfusion is mostly based on postpartum haemoglobin (Hb) values. RBC transfusion should be aimed to reduce morbidity and especially to improve Health Related Quality of Life (HRQoL). The goal of the WOMB study is to assess the effect of RBC transfusion on HRQoL and to confirm the role of HRQoL in deciding whether RBC transfusion is necessary.
详细描述
The WOMB study is a multicenter trial in patients with PPH, where a restrictive RBC transfusion policy will be compared with a more liberal RBC transfusion policy. Primary outcome in this study is fatigue measured with the MFI questionnaire. Inclusion criteria are: 1) 12-24 h after VD or CS; 2) 4.8 ≤Hb≤ 7.9 g/dL; 3) blood loss ≥ 1000mL or Hb decrease ≥ 1,9 g/dL; 4) age≥ 18 years; 5) no anaemic symptoms. Patients will be randomised for a RBC transfusion or not. The total follow-up period is 6 weeks. HRQoL will be measured at T=0 (12-24 hours postpartum) 3 days, 1, 3 and 6 weeks postpartum. At T=0 and 6 weeks postpartum Hb value will be measured. For the patients who receive a RBC transfusion, the effect of the RBC transfusion will be measured with the Hb value, Hct, platelet and leukocyte count, and the temperature of the patient before and after the RBC transfusion. The sample size is 500 patients: 250 allocated to a RBC transfusion and 250 patients allocated to a restrictive policy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women older than 18 years
- •12-24 hours after delivery (vaginal or caesarean section)
- •Patients are in a clinical obstetric setting
- •Blood loss of more than 1000 mL or Hb decrease ≥ 1,9 g/dL
- •Hb value between 4.8 g/dL and 7.9 g/dL
- •Working knowledge of the national language
- •Written consent for participating this study (informed consent)
排除标准
- •Patients with severe preeclampsia/ HELLP syndrome
- •RBC transfusion during or after delivery but before t=0
- •Patients with malignancy
- •Patients with severe congenital haemolytic disease, like thalassemia or sickle cell disease
- •Patients with compromised immunological status, congenital or acquired by medical treatment or infectious disease (eg. HIV)
- •Severe active infectious disease at the time of proposed inclusion
- •Severe cardiac, pulmonary, neurological, metabolic or psychiatric co- morbidity (ASA II/III) at the time of proposed inclusion
- •Severe physical complaints (tachycardia of more than 100 bpm, dyspnoea, syncope, heart problems) at the time of intended inclusion
- •Peripartum death of the newborn, or the newborn being in critical condition on neonatal intensive care
结局指标
主要结局
Physical Fatigue
时间窗: on day 3 postpartum
measured with the MFI questionnaire
次要结局
- Health related quality of life(delivery - six weeks postpartum)
- Blood usage and the costs(delivery - six weeks postpartum)
- Hemoglobin increase after transfusion(before- after transfusion)
- Heart beat, blood pressure, temperature(before- after transfusion)
- Hospital stay(delivery - six weeks postpartum)
- Physical complications (infections, thromboembolic events, hemodynamic events, cardiac events, neurologic events, secondary HPP, obstetric interventions, 'rescue' RBC transfusion) with WHO CTC grade 2 or more.(delivery - six weeks postpartum)