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NEDERLANDS





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Netherlands Obstetric Surveillance System


- candidate number15373
- NTR NumberNTR4160
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-sep-2013
- Secondary IDsP12.216/SH/sh METC LUMC
- Public TitleNetherlands Obstetric Surveillance System
- Scientific TitleNetherlands Obstetric Surveillance System
- ACRONYMNethOSS
- hypothesisCalculate 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 criteriaEclampsia:
Any woman with convulsion(s) during pregnancy or in the first 10 days postpartum, not attributable to other causes.

Cardiac arrest:
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 Either: Acute maternal collapse with one or more of the following features:
Acute fetal compromise
Cardiac arrest
Cardiac rhythm problems
Coagulopathy
Hypotension
Maternal hemorrhage*
Premonitory symptoms (restlessness, numbness, agitation, tingling)
Seizure
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
Or
Women in whom the diagnosis was made at post-mortem examination with the finding of fetal squames or hair in the lungs

Control group:
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 criteriaNot meeting inclusion criteria.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate31-aug-2015
- Target number of participants100
- Interventionsnone. Since this is an national observational study, there are no interventions applicable.
- Primary outcomeIncidence 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 outcomePutative risk factors, differences in management stratagies.

By using the control group analysis of different management stratagies will be performed.
- Timepoints
- Trial web sitewww.nethoss.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThe 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)
- RECORD5-sep-2013 - 29-sep-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl