Prevention of Maternal and Perinatal Complications by Enoxaparin in Women With Previous Severe Preeclampsia (HEPEPE)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00986765
First received: September 29, 2009
Last updated: October 29, 2014
Last verified: October 2014
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Purpose
Preeclampsia (PE) complicates 2-8% of pregnancies. It is associated with an increased risk of adverse maternal (death, eclampsia, abruptio placenta, HELLP syndrome) and perinatal (perinatal death, growth restriction, prematurity) outcomes. The only definite treatment of PE remains pregnancy termination. Therefore, prevention of PE remains an important challenge. Low dose aspirin may be used in the prevention of PE, particularly in women who had a severe preeclampsia before 34 weeks. Its efficiency, however, is very weak. Recently, it has been suggested that low molecular weight heparin might be useful in the prevention of PE.
The aim of this study is to analyze the usefulness of the enoxaparin 4000 UI/day in the prevention of a composite maternal or perinatal morbidity (occurrence of one of the following events: maternal death, PE, fetal growth retardation, abruptio placenta, perinatal death) in women who previously had a severe preeclampsia at less than 34 weeks' gestation. To answer this question, the investigators propose to conduct a multicenter prospective randomized trial that will compare two groups in parallel: a group where women will have an association of enoxaparin 4000 U/day and aspirin 100 mg/day and another group where women would have only aspirin 100 mg/day. The number of patients needed in each arm is 220.
| Condition | Intervention | Phase |
|---|---|---|
|
Preeclampsia |
Drug: Lovenox® (enoxaparin) Drug: Aspegic ® (Aspirin) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Low Molecular Weight Heparin, Enoxaparin, to Prevent Adverse Maternal and Perinatal Outcomes in Women With Previous Severe Preeclampsia at Less Than 34 Weeks' Gestation. A Prospective Randomized Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
preeclampsia
MedlinePlus related topics:
Blood Thinners
U.S. FDA Resources
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- The primary outcome is a composite morbidity that may occur : maternal death, or perinatal death, or preeclampsia, or abruptio placenta, or fetal growth restriction. [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Recurrence of preeclampsia alone [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Recurrence of severe preeclampsia [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Fetal growth restriction alone [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Severe fetal growth restriction (< 5th percentile) [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Perinatal death alone [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Neonatal death [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Abruption alone [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Maternal death [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Fetal loss (10-21 weeks) [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Fetal death [ Time Frame: from 15 weeks to delivery ] [ Designated as safety issue: No ]
- Recurrence of preeclampsia controlled for thrombophilia analysis (polymorphism of factor V Leiden, prothrombin G20210A gene polymorphism) [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Recurrence of preeclampsia controlled for angiogenic factors (free VEGF and PlGF, sFlt1, sEng) [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Neonatal morbidity (NICU transfer, length of hospitalization, mechanical ventilation > 24 hours, respiratory distress syndrome, necrotizing enterocolitis, periventricular leucomalacia, bronchopulmonary dysplasia, intraventricular hemorrhage grade III-IV) [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
- Enoxaparin toxicity: hemorrhage, skin reaction, thrombocytopenia (<100000/µL) related to heparin [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: Yes ]
- Bone fracture [ Time Frame: from randomization until one month after the delivery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 255 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lovenox® , 4000 UI/day (+ Aspegic®)
Lovenox® (enoxaparin), 4000 UI/day (+ Aspegic® (Aspirin), 100 mg)
|
Drug: Lovenox® (enoxaparin)
Injectable solution 4000 UI
Other Name: Lovenox® (enoxaparin)
|
|
Active Comparator: Aspegic ®, 100 mg/day
Aspegic® (Aspirin),100 mg/day
|
Drug: Aspegic ® (Aspirin)
100 mg/day
Other Name: Aspegic ® (Aspirin)
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient ≥ 18 years
- Patient with a previous severe preeclampsia that occurred at less than 34 weeks' gestation
- Patient between 7 and 13 weeks +6 days at first prenatal visit
- Singleton pregnancy
- Affiliation to social security
- Informed consent given after receiving information on the study.
Exclusion Criteria:
- Patient under law protection
- Inability to sign written consent
- Inability to follow the protocol because of a psychiatric disease
- History of deep venous thromboembolism during previous pregnancy
- Need of low molecular weight heparin during pregnancy
- Previous arterial thrombosis
- Patient having a cardiac valvular prosthesis that necessitates anticoagulation during pregnancy
- Renal failure (creatinine clearance < 30 ml/min, or serum creatinine > 180 µmol/L
- Previous hemorrhagic disease
- A disease that might bleed (gastric ulcer)
- Antiphospholipid antibody syndrome
- Allergy to Aspirin
- Allergy to heparins
- Thrombocytopenia related to heparin use
- Thrombocytopenia <100,000 /µL at first prenatal visit
- Antecedent of osteoporosis
- Inability to do subcutaneous injection of heparin
- Weight > 100 kg
- Patient included in another interventional trial
- Patient positive for anti-phospholipids antibodies
- Patient positive for HIV or HCV or HBS
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986765
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986765
Contacts
| Contact: Bassam Haddad | (0)1 45 17 55 82 ext +33 | Bassam.Haddad@chicreteil.fr | |
| Contact: Fatiha Djennaoui | (0)1 49 81 33 84 ext +33 | fatiha.djennaoui@hmn.aphp.fr |
Locations
| France | |
| Centre Hospitalier Intercommunal de Créteil | Recruiting |
| Creteil, France | |
| Contact: Bassam Haddad (0)1 45 17 55 82 ext +33 Bassam.Haddad@chicreteil.fr | |
| Contact: Fatiha Djennaoui (0) 1 49 81 33 84 ext +33 fatiha.djennaoui@hmn.aphp.fr | |
| Principal Investigator: Bassam Haddad | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Bassam Haddad | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00986765 History of Changes |
| Other Study ID Numbers: | P071211 |
| Study First Received: | September 29, 2009 |
| Last Updated: | October 29, 2014 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Fetal growth restriction Abruptio placentae Perinatal death |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Acetylsalicylic acid lysinate Aspirin Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antipyretics Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents |
Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015