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
ID
Bron
Verkorte titel
Aandoening
von Willebrand disease
hemophilia carrier
post partum hemorrhage (PPH)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The incidence of severe PPH, defined as 1000mL or more blood loss within the first 24 hours after delivery
Achtergrond van het onderzoek
‘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%.’
Doel van het onderzoek
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
Onderzoeksopzet
outcome assessment at one, six and twelve weeks post delivery
Onderzoeksproduct en/of interventie
three patient reported outcome questionaires after delivery
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6770 |
| NTR-old | NTR6947 |
| Ander register | MEC : 13-792 |