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Hypitat.


- candidate number1456
- NTR NumberNTR300
- ISRCTNISRCTN08132825
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleHypitat.
- Scientific TitlePregnancy-induced hypertension and pre-eclampsia after 36 weeks: induction of labour versus expectant monitoring. A comparison of maternal and neonatal outcome, maternal quality of life and costs.
- ACRONYMHypitat
- hypothesisEquivalence between maternal and neonatal outcome.
- Healt Condition(s) or Problem(s) studiedPregnancy induced hypertension, Pre-eclampsia
- Inclusion criteriaPregnant women wit gestational age 36 0/7 wks until 41 0/7 wks.
- Bloodpressure > 140/95 mm Hg. Eventually combined with proteinuria ( > 300 mg/ 24 hour).
- Exclusion criteria1. Treated hypertension before pregnancy,
diabtes mellitus;
2. Renal disease and previous caesarean section;
3. HELLP syndrome;
4. Oluguria;
5. Cerebral or visual disturbances;
6. Pulmonary edema or cyanosis;
7. Non vertex position.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-feb-2006
- planned closingdate1-feb-2009
- Target number of participants250
- InterventionsInduction of labour.
- Primary outcomeMaternal and neonatal outcome, quality of maternal life.
- Secondary outcomeEconimic analysis.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M. Pampus, van
- CONTACT for SCIENTIFIC QUERIESDr. M. Pampus, van
- Sponsor/Initiator ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-sep-2005 - 7-mrt-2006


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