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.

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

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

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

NTR300

Scientific title

Acronym

Hypitat (Hypertension and Preeclampsia Intervention Trial at Term)

Study hypothesis

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)

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

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

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

Overall study end date

01/04/2008

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Sex

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

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Groningen
Groningen
9700 RB
Netherlands

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/

ROR

https://ror.org/01yaj9a77

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

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs