To investigate the hypothesis that temporising treatment of women with early-onset, severe preeclampsia improves infant outcome and may reduce direct treatment costs in comparison to short-term planned delivery, while persistent maternal morbidity…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is composite major neonatal morbidity and perinatal
mortality.
Secondary outcome
The secondary long-term neonatal outcome is a Bailey assessment at two years
corrected age. 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. Cost analysis calculates direct
health care costs of mother and infant until discharge.
Background summary
During pregnancy hypertensive disorders are a frequent cause of maternal
morbidity and mortality and an important cause of neonatal morbidity and
mortality. The only effective treatment is termination of pregnancy, but at an
early gestational age this is questionable since temporising management and
prolongation of the pregnancy may possibly improve neonatal outcome. Present
obstetric knowledge is not sufficient to decide how to balance between the
risks of maternal complications and the benefits of the neonate.
Study objective
To investigate the hypothesis that temporising treatment of women with
early-onset, severe preeclampsia improves infant outcome and may reduce direct
treatment costs in comparison to short-term planned delivery, while persistent
maternal morbidity or death are comparable.
Study design
After admission for severe preeclampsia patients will be stabilised with
antihypertensive medication and magnesium sulphate and administered
corticosteroids for inducement of fetal maturity according to standard
practice. After 24 hours, patients, who did not develop a major maternal
complication after admission or a fetal indication for delivery, will be
randomised for either termination of pregnancy 48 hours after admission or for
expectant management. Randomisation will be stratified for gestational age
lower or higher than 31 weeks and for participating centre.
Intervention
Temporising of pregnancy starting 24 hours after randomisation. Pregnancy will
only be terminated when maternal and/or fetal complications occur or when the
gestational age of 34 weeks is reached.
Study burden and risks
At least the short-term health risks for the mother in the temporising schedule
seem to be acceptable in the clinical setting of a level III center. The direct
burden may be a longer stay in hospital, but this is customary until now. The
possible neonatal risks are unknown, but may be related to the degree of
prematurity, especially when delivered at an earlier stage. However, in
preeclamptic pregnancies the benefits of prolonging pregnancy may be
counteracted by the dangers of the underlying maternal disease. Also in case of
prolonging these pregnancies the length of prolonging is relatively short.
Dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
Dr. Molewaterplein 60
Rotterdam 3015 GJ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21849.078.08 |