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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39398
Enrollment
1130
Registered
2010-04-08
Start date
2011-02-15
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gestational hypertension toxicosis

Interventions

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.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary outcome is composite major neonatal morbidity and perinatal mortality.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)