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TOTEM study

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


Go to the TOTEM study website.


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 materinal 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 for 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 center.


Study population

All women with working knowledge of the Dutch language with severe preeclampsia, gestational age at inclusion of 27.8 - 33.5 weeks, singleton precnancy, estimated fetal weight > of equal to 500 gram and no known major fetal congenital anomalies.


Intervention

Temporising of pregnancy starting 24 hours after randomisation. Pregnancy will only be terminated when maternal and/or fetal complications occur when the gestational age of 34 weeks is reached.


Outcome measures

The primary outcome is composite major neonatal morbidity and perinatal morbidity.

The secundary long-term neonatal outcome is a Bailey assessment at two years corrected age. The secondary short-term maternal outcome is the occurence 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.


Nature and extent of the burden and risks associated with participation, benefit and group relatedness

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.


Time schedule

36 months.


Project leaders

Dr. J.J. Duvekot, Erasmus MC Rotterdam


Contact

Drs. Eline C. van der Wilk, Erasmus MC Rotterdam

010-7036109

e.vanderwilk@eramusmc.nl