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.

Completed

Conditions: Pre-eclampsia, pregnancy induced hypertension
Pregnancy and Childbirth
Gestational [pregnancy-induced] hypertension with significant proteinuria

Registration Number: ISRCTN08132825

Lead Sponsor: The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 250

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)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>Previous primary outcome measures (as of 22/08/2007):<br>Maternal and neonatal outcome, quality of maternal life.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be neonatal mortality or neonatal morbidity, instrumental delivery rate, severe maternal quality of life and quality of recovery and costs.<br><br>Previous secondary outcome measures (as of 22/08/2007):<br>Economic analysis