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Temporise or Terminate pregnancy in women with severe preeclampsia at 28-34 weeks.

Completed
Conditions
gestational hypertension
toxicosis
10026908
Registration Number
NL-OMON39398
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
1130
Inclusion Criteria

Informed consent
Working knowledge of Dutch language
Gestational age 27.6 - 33.5 weeks at inclusion
Estimated fetal weight >= 500 gram at inclusion
No major fetal congenital anomalies
Severe preeclampsia (modified from the criteria for severe preeclampsia (ACOG practice bulletin no. 33, table 1))

Exclusion Criteria

Therapy resistant hypertension
Severe maternal complications
Fetal indication for immediate delivery
Major fetal congenital anomalies or estimated fetal weight below 500 grams

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome is composite major neonatal morbidity and perinatal<br /><br>mortality. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary long-term neonatal outcome is a Bailey assessment at two years<br /><br>corrected age. The secondary short-term maternal outcome is the occurrence of<br /><br>major complications before and after delivery. The secondary long-term maternal<br /><br>outcome is persistent morbidity or death. Cost analysis calculates direct<br /><br>health care costs of mother and infant until discharge.</p><br>
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