NCT00335023

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

6.8 years

First QC Date

June 7, 2006

Last Update Submit

July 19, 2011

Conditions

Anemia

Keywords

postpartum hemorrhagered blood cell transfusionhealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • Physical Fatigue

    measured with the MFI questionnaire

    on day 3 postpartum

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Red blood cell transfusion

ACTIVE COMPARATOR

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

Other: Red blood cell transfusion

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

Interventions

Red blood cell transfusionOTHER

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

Red blood cell transfusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women older than 18 years
  • 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)

You may not qualify if:

  • 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)
  • Peripartum death of the newborn, or the newborn being in critical condition on neonatal intensive care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanquin Blood Bank South West Region

Rotterdam, 3001 KJ, Netherlands

Location

Related Publications (5)

  • 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.

    PMID: 41114449DERIVED

  • 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.

    PMID: 34932836DERIVED

  • 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.

    PMID: 25600160DERIVED

  • 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.

    PMID: 24405687DERIVED

  • 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.

    PMID: 21162725DERIVED

Related Links

MeSH Terms

Conditions

AnemiaPostpartum Hemorrhage

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

May 1, 2004

Primary Completion

March 1, 2011

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

NL(1)