|- candidate number||15373|
|- NTR Number||NTR4160|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-sep-2013|
|- Secondary IDs||P12.216/SH/sh METC LUMC|
|- Public Title||Netherlands Obstetric Surveillance System|
|- Scientific Title||Netherlands Obstetric Surveillance System|
|- hypothesis||Calculate the incidence of eclampsia; cardiac arrest and perimortem caesarean sectio in pregnancy or puerperium in the Netherlands.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||Eclampsia:|
Any woman with convulsion(s) during pregnancy or in the first 10 days postpartum, not attributable to other causes.
Any pregnant women in the Netherlands identified as receiving basic life support (chest compressions and, where possible, ventilation breaths), including women who have undergone PMCS.
Amniotic fluid embolism:
IN THE ABSENCE OF ANY OTHER CLEAR CAUSE
Acute maternal collapse with one or more of the following features:
• Acute fetal compromise
• Cardiac arrest
• Cardiac rhythm problems
• Maternal hemorrhage*
• Premonitory symptoms (restlessness, numbness, agitation, tingling)
• Shortness of breath
* Excluding women with maternal haemorrhage as the first presenting feature in whom there was no evidence of early coagulopathy or cardio-respiratory compromise
Women in whom the diagnosis was made at post-mortem examination with the finding of fetal squames or hair in the lungs
For every case of eclampsia, a matching control will be retriewed from the reporting hospital. Controls will be retriewed by using the hospital registrtion of deliveries. Controls a matched only of parity.
|- Exclusion criteria||Not meeting inclusion criteria.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-sep-2013|
|- planned closingdate||31-aug-2015|
|- Target number of participants||100|
|- Interventions||none. Since this is an national observational study, there are no interventions applicable. |
|- Primary outcome||Incidence
All variables will be ascertained from anonymised photocopies from case-files and entered in a secured database.
Incidence will be calculated using the CBS data on deliveries per anum. |
|- Secondary outcome||Putative risk factors, differences in management stratagies.
By using the control group analysis of different management stratagies will be performed.
|- Trial web site||www.nethoss.nl|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||The NethOSS is a national registration network of severe maternal morbidity. It uses a monthly mailing card to identify cases of specific form of morbidity to ascertain incidence, putative risc factors and managemengt strategies by retriewing this data from anonymised photocopies of case files. |
|- Main changes (audit trail)|
|- RECORD||5-sep-2013 - 29-sep-2013|