No registrations found.
ID
Source
Brief title
Health condition
von Willebrand disease
hemophilia carrier
post partum hemorrhage (PPH)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of severe PPH, defined as 1000mL or more blood loss within the first 24 hours after delivery
Secondary outcome
The incidence of primary PPH, defined as 500mL or more blood loss within the first 24 hours after delivery
The incidence of late PPH, defined as excessive vaginal blood loss between 24 hours and 12 weeks after delivery needing hospital admission
Results of the PRO questionnaires
Background summary
‘Postpartum hemorrhage (PPH) is a major cause of maternal mortality. The PPH incidence in women with von Willebrand disease (VWD) or carriers of hemophilia is twice as high as in the normal population. The primary aim of this prospective observational cohort study is to estimate the incidence of severe PPH ≥1000 mL in women with VWD and hemophilia carriers treated according to the revised National guideline for pregnancy management of these women and exclude an unacceptable high incidence of 20%.’
Study objective
We hypothesize that the occurrence of severe post partum hemorrhage will approache the incidence in the normal population after implementation of a revised national guideline on the management of pregnancy in women with VWD or hemophilia carriers
Study design
outcome assessment at one, six and twelve weeks post delivery
Intervention
three patient reported outcome questionaires after delivery
Karin Van Galen
Postbus 85500, 3508 GA Utrecht
Utrecht 3584 CX
The Netherlands
088 75 584 50; 003188 7550490
k.p.m.vangalen@umcutrecht.nl
Karin Van Galen
Postbus 85500, 3508 GA Utrecht
Utrecht 3584 CX
The Netherlands
088 75 584 50; 003188 7550490
k.p.m.vangalen@umcutrecht.nl
Inclusion criteria
-Ongoing pregnancy beyond 10 weeks after the last menstruation
-Carrier of hemophilia A or B or Von Willebrand disease type 1, type 2 or type 3
-Age >18 years
Exclusion criteria
-Another concomitant coagulation disorder that needs a deviation of the treatment advises according to the revised national guideline on the management of pregnancy in hemophilia carriers and von Willebrand disease
-Use of therapeutic or intermediate dose LMWH before delivery
-Inability to give informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6770 |
| NTR-old | NTR6947 |
| Other | MEC : 13-792 |