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zwangerschapsuitkomsten bij vrouwen met een erfelijke stollingsziekte


- candidate number28401
- NTR NumberNTR6947
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jan-2018
- Secondary IDs13-792 MEC
- Public Titlezwangerschapsuitkomsten bij vrouwen met een erfelijke stollingsziekte
- Scientific TitleAn observational study on PRegnancy outcome in women with Inherited bleeding DisordErs
- ACRONYMPRIDE study
- hypothesisWe 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
- Healt Condition(s) or Problem(s) studiedVon Willebrand disease, Hemophilia carrier , Post partum hemorrhage (PPH)
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mrt-2018
- planned closingdate1-mrt-2023
- Target number of participants135
- Interventionsthree patient reported outcome questionaires after delivery
- Primary outcomeThe incidence of severe PPH, defined as 1000mL or more blood loss within the first 24 hours after delivery
- Secondary outcomeThe 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
- Timepointsoutcome assessment at one, six and twelve weeks post delivery
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Karin Van Galen
- CONTACT for SCIENTIFIC QUERIES Karin Van Galen
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
World Federation of Hemophilia
- Publications
- Brief 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%.’
- Main changes (audit trail)
- RECORD5-jan-2018 - 26-jan-2018


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