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 | https://doi.org/10.1186/ISRCTN08132825 |
| Secondary identifying numbers | NTR300 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 19/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M. van Pampus
Scientific
Scientific
University Medical Centre Groningen
Department of Obstetrics and Gynecology
CMC5, Y4.179
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 6161 |
|---|---|
| m.van.pampus@og.umcg.nl |
Study information
| Study design | Multicentre randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | Hypitat (Hypertension and Preeclampsia Intervention Trial at Term) |
| Study objectives | Equivalence between maternal and neonatal outcome. |
| Ethics approval(s) | Approved by the Medical Ethical Committee of the University Medical Centre of Leiden (ref: p04.210) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2006 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 250 (750 as of 22/08/2007) |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Groningen
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
P.O. Box 93 245
Den Haag
2509 AE
Netherlands
| Phone | +31 (0)70 3495111 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | methods of valuation/preference protocol: | 04/07/2007 | Yes | No | |
| Protocol article | trial protocol: | 27/07/2007 | Yes | No | |
| Results article | results | 19/09/2009 | Yes | No | |
| Results article | results | 01/12/2010 | Yes | No | |
| Results article | results | 01/12/2011 | Yes | No | |
| Results article | results | 01/12/2011 | Yes | No | |
| Results article | results | 01/12/2011 | Yes | No | |
| Results article | results | 01/08/2012 | Yes | No |
