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Hypitat: Pregnancy-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.
ISRCTN ISRCTN08132825
DOI 10.1186/ISRCTN08132825
ClinicalTrials.gov identifier
EudraCT number
Public title Hypitat: Pregnancy-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.
Scientific title
Acronym Hypitat (Hypertension and Preeclampsia Intervention Trial at Term)
Serial number at source NTR300
Study hypothesis Equivalence between maternal and neonatal outcome.
Lay summary Not provided at time of registration
Ethics approval Approved by the Medical Ethical Committee of the University Medical Centre of Leiden (ref: p04.210)
Study design Multicentre randomised active controlled parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Pre-eclampsia, pregnancy induced hypertension
Participants - inclusion criteria Current inclusion criteria (as of 22/08/2007):
1. Pregnant women with gestational age 36 0/7 weeks until 41 0/7 weeks
2. Blood pressure greater than 140/95 mmHg in women with pregnancy induced hypertension
3. Blood pressure greater than 140/90 mmHg combined with proteinuria (greater than 300 mg/24 hours) in women with preeclampsia

Previous inclusion criteria:
1. Pregnant women with gestational age 36 0/7 wks until 41 0/7 wks
2. Blood pressure greater than 140/95 mmHg. Eventually combined with proteinuria (greater than 300 mg/24 hour)
Participants - exclusion criteria 1. Treated hypertension before pregnancy
2. Diabetes mellitus
3. Renal disease and previous caesarean section
4. HELLP syndrome
5. Oluguria
6. Cerebral or visual disturbances
7. Pulmonary oedema or cyanosis
8. Non-vertex position
Anticipated start date 01/02/2006
Anticipated end date 01/04/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 250 (750 as of 22/08/2007)
Interventions In the intervention group, patients get an induction of labour within 24 hours after randomisation. Patients with a cervix that is judged to be 'ripe' at vaginal examination (bishop score greater than 6), labour will be induced with amniotomy and augmentation with oxytocin. In case the cervix is judged to be 'unripe' (bishop score less than 6), cervical ripening will be stimulated with use of intracervical or intravaginal prostaglandines according to the local protocol.

In the expectant group, patients will be monitored until the onset of spontaneous delivery. In this group intervention is recommended in case the foetal or maternal condition does not justify expectant management anymore.

As of 06/01/2009, this record was updated to show the completed status based on the participant inclusion completion date of April 2008. The previous anticipated end date of this trial was 01/02/2009.
Primary outcome measure(s) The primary outcome measure will be maternal mortality or severe maternal morbidity. Severe maternal morbidity will be defined as diastolic BP greater than 110 mmHg, major postpartum haemorrhage, eclampsia, HELLP syndrome or abruptio placenta.

Previous primary outcome measures (as of 22/08/2007):
Maternal and neonatal outcome, quality of maternal life.
Secondary outcome measure(s) Secondary outcomes will be neonatal mortality or neonatal morbidity, instrumental delivery rate, severe maternal quality of life and quality of recovery and costs.

Previous secondary outcome measures (as of 22/08/2007):
Economic analysis
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Trial website
Publications 1. 2007 methods of valuation/preference protocol: http://www.ncbi.nlm.nih.gov/pubmed/17610715
2. 2007 trial protocol: http://www.ncbi.nlm.nih.gov/pubmed/17662114
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19656558
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20840526
5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21985398
6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20822426
7. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21740249
8. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22703475
Contact name Dr  M.  van Pampus
  Address University Medical Centre Groningen
Department of Obstetrics and Gynecology
CMC5, Y4.179
P.O. Box 30001
  City/town Groningen
  Zip/Postcode 9700 RB
  Country Netherlands
  Tel +31 (0)50 361 6161
  Email m.van.pampus@og.umcg.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
  Address P.O. Box 93 245
  City/town Den Haag
  Zip/Postcode 2509 AE
  Country Netherlands
  Tel +31 (0)70 3495111
  Fax +31 (0)70 3495100
  Email info@zonmw.nl
  Sponsor website: http://www.zonmw.nl/
Date applied 20/12/2005
Last edited 19/09/2012
Date ISRCTN assigned 20/12/2005
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