Clinical trial NCT00335023: Well Being of Obstetric Patients on Minimal Blood Transfusions
Official title: Well Being of Obstetric Patients on Minimal Blood Transfusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Keywords: postpartum hemorrhage
red blood cell transfusion
health related quality of life
Lead sponsor: Sanquin Research & Blood Bank Divisions
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2006-06-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Physical Fatigue
timeFrame: on day 3 postpartum
Secondary outcomes:
measure: Health related quality of life
timeFrame: delivery - six weeks postpartum
measure: Blood usage and the costs
timeFrame: delivery - six weeks postpartum
measure: Hemoglobin increase after transfusion
timeFrame: before- after transfusion
measure: Heart beat, blood pressure, temperature
timeFrame: before- after transfusion
measure: Hospital stay
timeFrame: delivery - six weeks postpartum
measure: 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.
timeFrame: delivery - six weeks postpartum
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Sanquin Blood Bank South West Region
Study officials:
affiliation: Sanquin Blood Bank South West Region
name: Dick J van Rhenen, Prof MD PhD
role: STUDY_CHAIR
affiliation: Department Obstetrics of Erasmus Medical center
name: Johannes J Duvekot, MD, PhD
role: STUDY_CHAIR
affiliation: Department Obstetrics of Erasmus Medical center
name: Babette W Prick, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
citation: Prick BW, Schuit E, Mignini L, Jansen AJ, van Rhenen DJ, Steegers EA, Mol BW, Duvekot JJ; EBM Connect Collaboration. Prediction of escape red blood cell transfusion in expectantly managed women with acute anaemia after postpartum haemorrhage. BJOG. 2015 Dec;122(13):1789-97. doi: 10.1111/1471-0528.13224. Epub 2015 Jan 20.
citation: Prick BW, Jansen AJ, Steegers EA, Hop WC, Essink-Bot ML, Uyl-de Groot CA, Akerboom BM, van Alphen M, Bloemenkamp KW, Boers KE, Bremer HA, Kwee A, van Loon AJ, Metz GC, Papatsonis DN, van der Post JA, Porath MM, Rijnders RJ, Roumen FJ, Scheepers HC, Schippers DH, Schuitemaker NW, Stigter RH, Woiski MD, Mol BW, van Rhenen DJ, Duvekot JJ. Transfusion policy after severe postpartum haemorrhage: a randomised non-inferiority trial. BJOG. 2014 Jul;121(8):1005-14. doi: 10.1111/1471-0528.12531. Epub 2014 Jan 10.
citation: Prick BW, Steegers EA, Jansen AJ, Hop WC, Essink-Bot ML, Peters NC, Uyl-de Groot CA, Papatsonis DN, Akerboom BM, Metz GC, Bremer HA, van Loon AJ, Stigter RH, van der Post JA, van Alphen M, Porath M, Rijnders RJ, Spaanderman ME, Schippers DH, Bloemenkamp KW, Boers KE, Scheepers HC, Roumen FJ, Kwee A, Schuitemaker NW, Mol BW, van Rhenen DJ, Duvekot JJ. Well being of obstetric patients on minimal blood transfusions (WOMB trial). BMC Pregnancy Childbirth. 2010 Dec 16;10:83. doi: 10.1186/1471-2393-10-83.