High Risk Pregnant WomenPhase 3HOPPENCT01388322
Low Weight Heparin prOphylaxis for Placental-Mediated Complications of PrEgnancy
A Phase 3 study testing Enoxaparin in people with High Risk Pregnant Women and Placental Insufficiency, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Pregnant Women, Placental Insufficiency, Preeclampsia
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 4 sitesSpain
- Study dates
- Mar 2012to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital Universitario Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, 08950
Parc sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, 08830
About this study
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
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.
- Being tested
- Enoxaparin
- Keywords
- Pregnancy, Preeclampsia, Placental insufficiency
- Medical subject headings
- Placental Insufficiency, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin | Experimental | Subcutaneous administration of one dose daily of enoxaparin Receives: Drug: Enoxaparin |
| expectant management | No intervention | Usual management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from date of randomization until the date of delivery (assessed up to 30 weeks)
Secondary outcomes (4)
Gestational age at birth
Gestational age at birth
Measured: from date of randomization until the date of delivery (assessed up to 30 weeks)
Days of hospitalization during pregnancy
Days of hospitalization during pregnancy
Measured: from randomization to the time of delivery (30 weeks)
Days of maternal hospitalization in the postpartum period
Days of maternal hospitalization in the postpartum period
Measured: from delivery until discharge (an expected average of one week)
Neonatal Data
weight, height, head circumference, Apgar score 1-5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications
Measured: after the delivery (an expected average of one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startMar 2012
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Sant Joan de Deu, Hospital de Cruces, Parc Sanitari Sant Joan de Déu
- Responsible party
- Sponsor
- Investigators
- Lluís Cabero, MD PhD, Study chair, Hospital Vall d'HebronElisa Llurba, MD, Principal investigator, Hospital Vall d'HebronMaria Dolores Gómez, MD, Principal investigator, Hospital Sant Joan de DeuTxantón Martínez-Astorquiza, MD, Principal investigator, Hospital de CrucesRaul De Diego, M.D., Principal investigator, Parc Sanitari Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388322
- Sponsor's protocol ID
- HOPPE-Trial
- Other IDs
- 2010-023597-39
- Acronym
- HOPPE
- Status last verified
- Dec 2016
- First submitted
- 28 Jun 2011
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01388322
- Acronym / sponsor ID
- HOPPE / HOPPE-Trial
- Keywords
- Pregnancy, Preeclampsia, Placental insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Sant Joan de Deu, Hospital de Cruces, Parc Sanitari Sant Joan de Déu
- Study start
- Mar 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin | Experimental | Drug: EnoxaparinSubcutaneous administration of one dose daily of enoxaparin |
| expectant management | No intervention | –Usual management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant women ≥18 years
- Gestational age < 14 weeks at randomisation
- One or more of the following complications in a previous pregnancy:
- Uterine arteries Pulsatility Index (mPI) Doppler ≥95th percentile at 11-14 weeks of gestation.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin40 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. | Drug | Enoxaparin |
Primary outcome
Development of any of these complications of placental insufficiency
Time frame: 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
4 secondary outcomes
Gestational age at birth
Time frame: from date of randomization until the date of delivery (assessed up to 30 weeks)
Days of hospitalization during pregnancy
Time frame: from randomization to the time of delivery (30 weeks)
Days of maternal hospitalization in the postpartum period
Time frame: from delivery until discharge (an expected average of one week)
Neonatal Data
Time frame: after the delivery (an expected average of one month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lluís Cabero, MD PhD study chair
Hospital Vall d'Hebron
Elisa Llurba, MD principal investigator
Hospital Vall d'Hebron
Maria Dolores Gómez, MD principal investigator
Hospital Sant Joan de Deu
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enoxaparin in people with High Risk Pregnant Women and Placental Insufficiency, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of any of these complications of placental insufficiency (time frame: from date of randomization until the date of delivery (assessed up to 30 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.