Severe obstetrical complications Pregnancy and Childbirth Obstetrical complications
Conditions
Interventions
Randomisation (1:1) to dalteparin (5000 IU daily) versus no treatment from randomisation until 36 - 37 weeks of pregnancy. Total duration of follow-up for all treatment arms will be from randomisation
Sponsors
Canadian Foundation for Women's Health (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Normal thrombotic screen 2. Female patients aged more than 17 years 3. Pregnancy less than 17 weeks 4. Signature of the consent form 5. One of the following in previous pregnancy: 5.1. Severe preeclampsia with delivery less than 34 weeks 5.2. Severe intrauterine growth restriction (IUGR) 5.3. Abruptio placentae with delivery less than 34 weeks or foetal death 5.4. One idiopathic foetal death after 20 weeks 5.5. Two or more of idiopathic foetal death between 12 - 19 weeks
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancy 2. Alcohol or illicit drug use 3. Severe medical condition other than chronic hypertension 4. Foetal malformation or chromosomal anomaly 5. Uterine malformation or infection 6. Abdominal trauma 7. Any known cause of foetal death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome of one of: 1. Severe preeclampsia 2. Severe IUGR 3. Major abruptio placentae Primary outcomes will be measured at delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Non-severe preeclampsia, measured at delivery 2. Non-severe IUGR, measured at delivery 3. Gestational age at delivery, measured at delivery 4. Pregnancy complications, measured at delivery 5. Hospitalisation length, measured at delivery and departure from the hospital after delivery 6. Admission to intensive care unit, measured at departure from the hospital after delivery | — |
Countries
Canada
Outcome results
None listed