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Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy (HOPPE)

Primary Purpose

High Risk Pregnant Women, Placental Insufficiency, Preeclampsia

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Risk Pregnant Women focused on measuring Pregnancy, Preeclampsia, Placental insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Sant Joan de Deu
  • Parc sanitari Sant Joan de Deu
  • Hospital de Cruces
  • Hospital Universitario Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enoxaparin

expectant management

Arm Description

Subcutaneous administration of one dose daily of enoxaparin

Usual management

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Gestational age at birth
Gestational age at birth
Days of hospitalization during pregnancy
Days of hospitalization during pregnancy
Days of maternal hospitalization in the postpartum period
Days of maternal hospitalization in the postpartum period
Neonatal Data
weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications

Full Information

First Posted
June 28, 2011
Last Updated
December 20, 2016
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Hospital Vall d'Hebron, Hospital Sant Joan de Deu, Hospital de Cruces, Parc Sanitari Sant Joan de Déu
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1. Study Identification

Unique Protocol Identification Number
NCT01388322
Brief Title
Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy
Acronym
HOPPE
Official Title
Enoxaparin for the Prevention of Placental-Mediated Complications of Pregnancy in Women With Obstetric History or Abnormal Uterine Artery Doppler at First Trimester Ultrasound and Without Thrombophilia: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Hospital Vall d'Hebron, Hospital Sant Joan de Deu, Hospital de Cruces, Parc Sanitari Sant Joan de Déu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Pregnant Women, Placental Insufficiency, Preeclampsia
Keywords
Pregnancy, Preeclampsia, Placental insufficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
361 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin
Arm Type
Experimental
Arm Description
Subcutaneous administration of one dose daily of enoxaparin
Arm Title
expectant management
Arm Type
No Intervention
Arm Description
Usual management
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Development of any of these complications of placental insufficiency
Description
Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise
Time Frame
from date of randomization until the date of delivery (assessed up to 30 weeks)
Secondary Outcome Measure Information:
Title
Gestational age at birth
Description
Gestational age at birth
Time Frame
from date of randomization until the date of delivery (assessed up to 30 weeks)
Title
Days of hospitalization during pregnancy
Description
Days of hospitalization during pregnancy
Time Frame
from randomization to the time of delivery (30 weeks)
Title
Days of maternal hospitalization in the postpartum period
Description
Days of maternal hospitalization in the postpartum period
Time Frame
from delivery until discharge (an expected average of one week)
Title
Neonatal Data
Description
weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications
Time Frame
after the delivery (an expected average of one month)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lluís Cabero, MD PhD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elisa Llurba, MD
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Dolores Gómez, MD
Organizational Affiliation
Hospital Sant Joan de Deu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Txantón Martínez-Astorquiza, MD
Organizational Affiliation
Hospital de Cruces
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul De Diego, M.D.
Organizational Affiliation
Parc Sanitari Sant Joan de Deu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Parc sanitari Sant Joan de Deu
City
Sant Boi de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08830
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

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Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy

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