Well Being of Obstetric Patients on Minimal Blood Transfusions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Red blood cell transfusion

At least one unit of red blood cells will be administered.

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

At least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Red blood cell transfusion

At least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes