Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/09/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M. van Pampus

ORCID ID

Contact details

University Medical Centre Groningen
Department of Obstetrics and Gynecology
CMC5
Y4.179
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 6161
m.van.pampus@og.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR300

Study information

Scientific title

Acronym

Hypitat (Hypertension and Preeclampsia Intervention Trial at Term)

Study hypothesis

Equivalence between maternal and neonatal outcome.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-eclampsia, pregnancy induced hypertension

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/02/2006

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

250 (750 as of 22/08/2007)

Participant 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

Recruitment start date

01/02/2006

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

P.O. Box 93 245
Den Haag
2509 AE
Netherlands
+31 (0)70 3495111
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Vijgen SM, Koopmans CM, Opmeer BC, Groen H, Bijlenga D, Aarnoudse JG, Bekedam DJ, van den Berg PP, de Boer K, Burggraaff JM, Bloemenkamp KW, Drogtrop AP, Franx A, de Groot CJ, Huisjes AJ, Kwee A, van Loon AJ, Lub A, Papatsonis DN, van der Post JA, Roumen FJ, Scheepers HC, Stigter RH, Willekes C, Mol BW, Van Pampus MG, , An economic analysis of induction of labour and expectant monitoring in women with gestational hypertension or pre-eclampsia at term (HYPITAT trial)., BJOG, 2010, 117, 13, 1577-1585, doi: 10.1111/j.1471-0528.2010.02710.x.

  2. Results

    van der Tuuk K, Koopmans CM, Groen H, Mol BW, van Pampus MG, , Impact of the HYPITAT trial on doctors' behaviour and prevalence of eclampsia in the Netherlands., BJOG, 2011, 118, 13, 1658-1660, doi: 10.1111/j.1471-0528.2011.03138.x.

  3. Results

    Koopmans CM, Zwart JJ, Groen H, Bloemenkamp KW, Mol BW, Van Pampus MG, Van Roosmalen J, Risk indicators for eclampsia in gestational hypertension or mild preeclampsia at term., Hypertens Pregnancy, 2011, 30, 4, 433-446, doi: 10.3109/10641955.2010.506236.

  4. Results

    Bijlenga D, Koopmans CM, Birnie E, Mol BW, van der Post JA, Bloemenkamp KW, Scheepers HC, Willekes C, Kwee A, Heres MH, Van Beek E, Van Meir CA, Van Huizen ME, Van Pampus MG, Bonsel GJ, Health-related quality of life after induction of labor versus expectant monitoring in gestational hypertension or preeclampsia at term., Hypertens Pregnancy, 2011, 30, 3, 260-274, doi: 10.3109/10641955.2010.486458.

  5. Results

    Tajik P, van der Tuuk K, Koopmans CM, Groen H, van Pampus MG, van der Berg PP, van der Post JA, van Loon AJ, de Groot CJ, Kwee A, Huisjes AJ, van Beek E, Papatsonis DN, Bloemenkamp KW, van Unnik GA, Porath M, Rijnders RJ, Stigter RH, de Boer K, Scheepers HC, Zwinderman AH, Bossuyt PM, Mol BW, Should cervical favourability play a role in the decision for labour induction in gestational hypertension or mild pre-eclampsia at term? An exploratory analysis of the HYPITAT trial., BJOG, 2012, 119, 9, 1123-1130, doi: 10.1111/j.1471-0528.2012.03405.x.

  6. Bijlenga D, Birnie E, Mol BW, Bonsel GJ, When outcome is a balance: methods to measure combined utility for the choice between induction of labour and expectant management in mild risk pregnancy at term., BMC Pregnancy Childbirth, 2007, 7, 10, doi: 10.1186/1471-2393-7-10.

  7. Koopmans CM, Bijlenga D, Aarnoudse JG, van Beek E, Bekedam DJ, van den Berg PP, Burggraaff JM, Birnie E, Bloemenkamp KW, Drogtrop AP, Franx A, de Groot CJ, Huisjes AJ, Kwee A, le Cessie S, van Loon AJ, Mol BW, van der Post JA, Roumen FJ, Scheepers HC, Spaanderman ME, Stigter RH, Willekes C, van Pampus MG, Induction of labour versus expectant monitoring in women with pregnancy induced hypertension or mild preeclampsia at term: the HYPITAT trial., BMC Pregnancy Childbirth, 2007, 7, 14, doi: 10.1186/1471-2393-7-14.

  8. Koopmans CM, Bijlenga D, Groen H, Vijgen SM, Aarnoudse JG, Bekedam DJ, van den Berg PP, de Boer K, Burggraaff JM, Bloemenkamp KW, Drogtrop AP, Franx A, de Groot CJ, Huisjes AJ, Kwee A, van Loon AJ, Lub A, Papatsonis DN, van der Post JA, Roumen FJ, Scheepers HC, Willekes C, Mol BW, van Pampus MG, , Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial., Lancet, 2009, 374, 9694, 979-988, doi: 10.1016/S0140-6736(09)60736-4.

Additional files

Editorial Notes