AnemiaPhase 4WOMBNCT00335023
Well Being of Obstetric Patients on Minimal Blood Transfusions
A Phase 4 study testing Red blood cell transfusion in people with Anemia, run by Sanquin Research & Blood Bank Divisions at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2004to Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Red blood cell transfusion
- Keywords
- postpartum hemorrhage, red blood cell transfusion, health related quality of life
- Medical subject headings
- Anemia, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Red blood cell transfusion | Active comparator | At least one unit of red blood cells will be administered. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Fatigue
measured with the MFI questionnaire
Measured: on day 3 postpartum
Secondary outcomes (6)
Health related quality of life
Health related quality of life measured with the following questionnaires: Euro-Qol, SF-36 and the MFI
Measured: delivery - six weeks postpartum
Blood usage and the costs
Measured: delivery - six weeks postpartum
Hemoglobin increase after transfusion
Hb value and platelet count will be measured before and after red blood cell transfusion
Measured: 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
Measured: 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
Measured: 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
Measured: delivery - six weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startMay 2004
- Primary completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanquin Research & Blood Bank Divisions
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Investigators
- Dick J van Rhenen, Prof MD PhD, Study chair, Sanquin Blood Bank South West RegionJohannes J Duvekot, MD, PhD, Study chair, Department Obstetrics of Erasmus Medical centerBabette W Prick, M.D., Principal investigator, Department Obstetrics of Erasmus Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335023
- Sponsor's protocol ID
- 01-021b
- Other IDs
- 0904, NTR335
- Acronym
- WOMB
- Status last verified
- Jul 2011
- First submitted
- 7 Jun 2006
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41114449Carson 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.
PubMed 34932836Prick 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.
PubMed 25600160Prick 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.
PubMed 24405687Prick 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.
PubMed 21162725
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Well Being of Obstetric Patients on Minimal Blood Transfusions
- ClinicalTrials.gov ID
- NCT00335023
- Acronym / sponsor ID
- WOMB / 01-021b
- Conditions
- Anemia
- Keywords
- postpartum hemorrhage, red blood cell transfusion, health related quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sanquin Research & Blood Bank DivisionsUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- May 2004
- Primary completion
- Mar 2011 (actual)
- First posted
- 8 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red blood cell transfusion | Active comparator | Other: Red blood cell transfusionAt 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusionAt least one unit of red blood cells will be administered. The target Hb value after transfusion is at least 8.7 g/dL. | Other | Red blood cell transfusion |
Primary outcome
Physical Fatigue
Time frame: on day 3 postpartum
measured with the MFI questionnaire
6 secondary outcomes
Health related quality of life
Time frame: delivery - six weeks postpartum
Blood usage and the costs
Time frame: delivery - six weeks postpartum
Hemoglobin increase after transfusion
Time frame: before- after transfusion
Heart beat, blood pressure, temperature
Time frame: before- after transfusion
Hospital stay
Time frame: 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.
Time frame: delivery - six weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Derived from this study: PubMed 41114449Carson 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.
- Derived from this study: PubMed 34932836Carson 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.
- Derived from this study: PubMed 25600160Prick 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.
- Derived from this study: PubMed 24405687Prick 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.
- Derived from this study: PubMed 21162725Prick 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.
- study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dick J van Rhenen, Prof MD PhD study chair
Sanquin Blood Bank South West Region
Johannes J Duvekot, MD, PhD study chair
Department Obstetrics of Erasmus Medical center
Babette W Prick, M.D. principal investigator
Department Obstetrics of Erasmus Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Red blood cell transfusion in people with Anemia, run by Sanquin Research & Blood Bank Divisions at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Fatigue (time frame: on day 3 postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335023, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.