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Expectant or active management in women with severe preeclampsia at 28-34 weeks.


- candidate number10155
- NTR NumberNTR2986
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2011
- Secondary IDs2008-151 MEC Erasmus MC
- Public TitleExpectant or active management in women with severe preeclampsia at 28-34 weeks.
- Scientific TitleTemporise or Terminate pregnancy in women with severe preeclampsia at 28-34 weeks.
- ACRONYM
- hypothesisDuring 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.
- Healt Condition(s) or Problem(s) studiedPre-eclampsia
- Inclusion criteria1. Informed consent;
2. Working knowledge of Dutch language;
3. Gestational age 27.6 33.5 weeks at inclusion;
4. Estimated fetal weight ≥ 500 gram at inclusion;
5. No major fetal congenital anomalies;
6. Severe preeclampsia (modified from the criteria for severe preeclampsia (ACOG practice bulletin no. 33, table 1)): Preeclampsia (hypertension with proteinuria ≥ 0.3 g/24 hrs) and one or more of the following criteria:
A. Clinical symptoms like cerebral or visual disturbances (e.g. headache) and/or right upper quadrant or epigastric pain;
B. Laboratory abnormalities: thrombocytopenia (< 100 x 109/L) and/or impaired liver function tests (ASAT/ALAT ≥ 70 U/L and lactic dehydrogenase (LDH) ≥ 600 U/L) and/or haptoglobin < 0.2 g/L;
C. Severe hypertension with intravenous antihypertensive medication (systolic ≥160 mmHg and/or diastolic ≥110 mmHg).
- Exclusion criteria1. 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;
3. Therapy-resistant hypertension, defined as persistent blood pressure diastolic > 110 mm Hg and/or systolic > 160 mm Hg despite maximum medication according to protocol;
4. Placental abruption;
5. Clinically relevant pulmonary edema, defined as clinically relevant respiratory failure or severe respiratory distress requiring oxygen supplementation (more than 10 litres), with rales and/or pulse oximetry of <94% on room air;
6. Eclampsia;
7. (Sub)capsular liverhematoma;
8. Acute fatty liver of pregnancy;
9. Renal failure (oliguria and/or enlarged creatinine level);
10. Cerebro-vascular incident;
11. Trombo-embolism;
12. Other severe maternal complications.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 27-jun-2011
- planned closingdate27-jun-2014
- Target number of participants1130
- InterventionsAfter 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 or a fetal indication for delivery, will be randomised for either termination of pregnancy 48 hours after admission or for expectant management.
- Primary outcomeThe primary outcome is composite major neonatal morbidity and perinatal mortality.
- Secondary outcomeThe secondary long-term neonatal outcome is a Bailey-3 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.
- TimepointsThe primary outcome is composite major neonatal morbidity and perinatal mortality.
The secondary long-term neonatal outcome is a Bailey-3 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.
- Trial web sitehttp://www.studies-obsgyn.nl/totem
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Eline Wilk, van de
- CONTACT for SCIENTIFIC QUERIES Hans Duvekot
- Sponsor/Initiator Dutch consortium for studies in obstetrics, gynaecology, fertility, neonatology, gynaecological oncology, and urogynaecology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryPreeclampsia is a multisystem disorder defined by hypertension and proteinuria, which occurs during the second half of pregnancy or during the first days after delivery. It is one of the most common complications of pregnancy. When severe, it can involve the woman's liver, kidneys, clotting system, or brain as well as the placenta and can lead to death or serious health problems for the woman and/or her child. 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. In the treatment of obstetric complications one has to consider two patients with different interests and risk for complications. After a gestational age of over 34 weeks the risk for neonatal complications is low and intervention in the interest of the mother is usually performed in case of severe maternal disease. Below 28 weeks neonatal risk is extremely high, and, if fetal condition allows prolongation of pregnancy, then this is clearly in the interest of the infant. Between 28 and 34 weeks the balance between maternal and infant risk is uncertain. This clinical dilemma is relatively frequent in most level III perinatal units, and currently decisions are based mainly upon personal experience rather than good evidence. The TOTEM trial investigates the hypothesis that temporising treatment of women with early-onset, severe preeclampsia with a gestational age between 28-34 weeks does not improve infant outcome as compared to termination of pregnancy 48 hours after admission and administering corticosteroids for inducement of fetal maturity.
- Main changes (audit trail)
- RECORD14-jul-2011 - 30-aug-2011


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