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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01388322
Other study ID # HOPPE-Trial
Secondary ID 2010-023597-39
Status Completed
Phase Phase 3
First received June 28, 2011
Last updated December 20, 2016
Start date March 2012
Est. completion date December 2016

Study information

Verified date December 2016
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 361
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
Enoxaparin
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.

Locations

Country Name City State
Spain Hospital de Cruces Barakaldo Vizcaya
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Hospital Sant Joan de Deu Esplugues de Llobregat Barcelona
Spain Parc sanitari Sant Joan de Deu Sant Boi de Llobregat Barcelona

Sponsors (5)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute Hospital de Cruces, Hospital Sant Joan de Deu, Hospital Vall d'Hebron, Parc Sanitari Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Development of any of these complications of placental insufficiency Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise from date of randomization until the date of delivery (assessed up to 30 weeks) No
Secondary Gestational age at birth Gestational age at birth from date of randomization until the date of delivery (assessed up to 30 weeks) No
Secondary Days of hospitalization during pregnancy Days of hospitalization during pregnancy from randomization to the time of delivery (30 weeks) No
Secondary Days of maternal hospitalization in the postpartum period Days of maternal hospitalization in the postpartum period from delivery until discharge (an expected average of one week) No
Secondary Neonatal Data weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications after the delivery (an expected average of one month) No
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