Well Being of Obstetric Patients on Minimal Blood Transfusions

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Well Being of Obstetric Patients on Minimal Blood Transfusions

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Other: Red blood cell transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Red blood cell transfusion<br>At least one unit of red blood cells will be administered. | Other: Red blood cell transfusion<br>* At least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL.<br>|
| No Intervention: Control<br>No red blood cell transfusion. Iron suppletion is allowed and can be administered according to local protocol. If suppletion is prescribed, the type and duration will be registered | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Fatigue | measured with the MFI questionnaire | on day 3 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | Health related quality of life measured with the following questionnaires: Euro-Qol, SF-36 and the MFI | delivery - six weeks postpartum | 
| Blood usage and the costs |  | delivery - six weeks postpartum | 
| Hemoglobin increase after transfusion | Hb value and platelet count will be measured before and after red blood cell transfusion | before- after transfusion | 
| Heart beat, blood pressure, temperature | heart beat per minute, blood pressure, temperature will be measured before and after red blood cell transfusion | before- after transfusion | 
| Hospital stay | the hospital stay after delivery will be compared between both arms. All admissions in the first 6 weeks postpartum will be registered | 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. | all complications and admissions in the first 6 weeks postpartum will be registered | delivery - six weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum hemorrhage, red blood cell transfusion, health related quality of life