Expectant or active management in women with severe preeclampsia at 28-34 weeks.
Recruiting
- Conditions
- All women with working knowledge of the Dutch language with severe preeclampsia, gestational age at inclusion of 27.6-33.5 weeks, singleton pregnancy, estimated fetal weight ¡Ý 500 gram and no known major fetal congenital anomalies.Ernstige preeclampsie, zwangerschapsduur 27.6-33.5 weken, geschat gewicht boven 500 gram zonder ernstige structurele afwijkingen
- Registration Number
- NL-OMON23179
- Lead Sponsor
- Dutch consortium for studies in women's health and reproductivity.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1130
Inclusion Criteria
1. Informed consent;
2. Working knowledge of Dutch language;
Exclusion Criteria
1. Fetal indication for immediate delivery, ie. signs of fetal distress: Spontaneous repeated persistent unprovoked decelerations on CTG;
2. Fetal death or major fetal congenital anomalies or estimated fetal weight below 500 grams;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is composite major neonatal morbidity and perinatal mortality. <br><br>
- Secondary Outcome Measures
Name Time Method The secondary long-term neonatal outcome is a Bailey-3 assessment at two years corrected age.<br /> The secondary short-term maternal outcome is the occurrence of major complications before and after delivery. The secondary long-term maternal outcome is persistent morbidity or death.