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| ID | Type | Description | Link |
|---|---|---|---|
| 0904 | Other Grant/Funding Number | Landsteiner Foundation for Blood Transfusion Research | |
| NTR335 | Registry Identifier | Nederlandse Trial Registratie |
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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Red blood cell transfusion | Active Comparator | At least one unit of red blood cells will be administered. |
|
| Control | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cell transfusion | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Fatigue | measured with the MFI questionnaire | on day 3 postpartum |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dick J van Rhenen, Prof MD PhD | Sanquin Blood Bank South West Region | Study Chair |
| Johannes J Duvekot, MD, PhD | Department Obstetrics of Erasmus Medical center | Study Chair |
| Babette W Prick, M.D. | Department Obstetrics of Erasmus Medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanquin Blood Bank South West Region | Rotterdam | 3001 KJ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. | |
| 34932836 | Derived |
| Label | URL |
|---|---|
| study website | View source |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 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 |
| 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. |
| 25600160 | Derived | 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. |
| 24405687 | Derived | 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. |
| 21162725 | Derived | 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. |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |