High Risk Pregnant Women, Placental Insufficiency, Preeclampsia
Conditions
Keywords
Pregnancy, Preeclampsia, Placental insufficiency
Brief summary
This is a Multicenter, randomized, open-label, parallel groups study to test the hypothesis that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks of gestation could improve maternal and perinatal outcome in women at high risk for developing placental-mediated pregnancy complications.
Interventions
DRUGEnoxaparin
40 mg (4000 IU) women \<80 kg at the time of randomization or 60 mg (6000 IU) women\> 80 kg at the time of randomization One dose daily. Subcutaneous administration. Treatment periods: the same day of the Initiation visit (from 9 to 13.6 weeks of gestation) until 36 weeks gestation.
Sponsors
Hospital Vall d'Hebron
Hospital Sant Joan de Deu
Hospital de Cruces
Parc Sanitari Sant Joan de Déu
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women ≥18 years * Gestational age \< 14 weeks at randomisation * One or more of the following complications in a previous pregnancy: * Severe PE resulting in delivery before 32 weeks of gestation * Newborn weight less than the 10th percentile and documented abnormal Doppler in the umbilical artery during pregnancy before 32 weeks gestation * Abruption of placenta * Unexplained intrauterine death between 20-41,6 weeks of gestation secondary of placental insufficiency or * Uterine arteries Pulsatility Index (mPI) Doppler ≥95th percentile at 11-14 weeks of gestation.
Exclusion criteria
* Multiple pregnancy * Abnormal thrombophilia study * Alcohol or illicit drug use * Severe fetal malformations or chromosomal abnormalities * Previous history of infertility ( 3 or more early miscarriages) * Maternal HIV, Cytomegalovirus or toxoplasma infection * Known fetal abnormality or chromosomal defect at randomisation * Women with previous venous or arterial thrombotic event * Organic lesions that could increase the hemorrhagic risk: gastric ulcus, stroke, a recent hemorrhagic event, high risk situations for hemorrhagic event * Known allergy to heparin or LMWH, thrombopenia or thrombosis episode due to heparin treatment * Contraindication to LMWH * An absolute indication for anticoagulant therapy: venous deep thrombosis, pulmonary embolism, ovaric hyperestimulation, cardiophaty, others * Metabolic disorders a risk for development of PE and/or IUGR: Type I diabetes, hipertiroidism, chronic renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of any of these complications of placental insufficiency | from date of randomization until the date of delivery (assessed up to 30 weeks) | Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at birth | from date of randomization until the date of delivery (assessed up to 30 weeks) | Gestational age at birth |
| Days of hospitalization during pregnancy | from randomization to the time of delivery (30 weeks) | Days of hospitalization during pregnancy |
| Days of maternal hospitalization in the postpartum period | from delivery until discharge (an expected average of one week) | Days of maternal hospitalization in the postpartum period |
| Neonatal Data | after the delivery (an expected average of one month) | weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications |
Countries
Spain
Outcome results
None listed