Low molecular weight heparin (FRagmin (R)) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia, a randomized trial (FRUIT-study).

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.

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.

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.