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ID
Source
Brief title
Health condition
The pregnant women are randomised after ultrasound confirmation of a viable intrauterine pregnancy to recieve daily dalteparin plus aspirin (starting before 12 weeks gestation) or aspirin only.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of preeclampsia before 34 weeks gestational age.
Secondary outcome
1. Reduction in spontaneous abortion, maternal admission to hospital and neonatal intensive care admission;
2. Increase in gestational age and weight at birth.
Background summary
Uteroplacental insufficiency resulting in preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes and low platelets) fetal growth restriction and preterm birth is one of the major problems in perinatal medicine.
The origin is multifactorioal and endothelial cell dysfunction is the final common pathway in the maternal syndrome preeclampsia. A substantial percentage of the women have thrombophilic disorders.
This multicenter open two-armed RCT will elucidate whether treatment with low molecular weight heparine during a following pregnancy is benificial for the maternal, fetal and neonatal morbidity and mortality.
Study objective
Low molecular weight heparin plus aspirin reduces the recurrence of preeclampsia and/or small for gestational age infants before 34 weeks gestational age in women with documented thrombophilia with a history of preeclampsia and/or small for gestational age infants with birth before 34 weeks.
Intervention
Two armed study:
A: Daily dalteparin (starting between 6-12 weeks pregnancy) throughout gestation plus aspirin (starting before 12 weeks gestation to 36 weeks);
B: Aspirin only ( starting before 12 weeks to 36 weeks).
Both arms receive regular controls for women with a history of preeclampsia. In arm A: examination of Anti FActor Xa activity at 20 and 30 weeks.
P.O. Box 7057
J.I.P. Vries, de
Amsterdam 1007 MB
The Netherlands
JIP.deVries@VUMC.nl
P.O. Box 7057
J.I.P. Vries, de
Amsterdam 1007 MB
The Netherlands
JIP.deVries@VUMC.nl
Inclusion criteria
1. Patients with a history of preeclampsia and/or small for gestaitonal age infants before 34 weeks gestation and documented thrombophilia restricted to proteine c and proteine S deficiency, APC resistance, Factor V Leiden mutation, FActor II mutation, anticardiolipin antibodies, lupus anticoagulant;
2. Age > 18 years;
3. Informed consent.
Exclusion criteria
1. Antithrombine deficiency;
2. Diabetes mullitus;
3. Known malignancy;
4. Gastro-duodenic ulcer;
5. Severe renal or hepatic insufficiency;
6. Thrombo-embolism in history;
7. Hemorrhagic diathesis;
8. Idiopathic thrombocytopenia.
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 |
|---|---|
| NTR-new | NL299 |
| NTR-old | NTR337 |
| Other | : N/A |
| ISRCTN | ISRCTN87325378 |