Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335023
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2006-06-07
Brief Title:
Well Being of Obstetric Patients on Minimal Blood Transfusions
Sponsor:
Sanquin Research Blood Bank Divisions
Organization:
Sanquin Research Blood Bank Divisions
Study Overview
Official Title:
Well Being of Obstetric Patients on Minimal Blood Transfusions
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WOMB
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 48 Hb 79 gdL 3 blood loss 1000mL or Hb decrease 19 gdL 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 T0 12-24 hours postpartum 3 days 1 3 and 6 weeks postpartum At T0 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NTR335 | REGISTRY | Nederlandse Trial Registratie | None |
| 0904 | OTHER_GRANT | None | None |