Placental InsufficiencyPhase 4PRESANCENCT03528967
Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
A Phase 4 study testing Enoxaparin 40 mg / 0.4 mL Prefilled Syringe and Aspirin 100 mg Oral Tablet, Enteric Coated in people with Placental Insufficiency and Enoxaparin, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial summary
Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placental Insufficiency, Enoxaparin
- What is being tested?
- Enoxaparin 40 mg / 0.4 mL Prefilled Syringe and Aspirin 100 mg Oral Tablet, Enteric Coated
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTunisia
- Study dates
- 23 Oct 2013to 31 Jul 2018
- Phase
- Phase 4
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years and
- Age ≤ 45 years and
- Single and confirmed pregnancy and
- Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) < 3rd percentile and / or
- In utero fetal death (IUFD) history > 12 weeks of amenorrhea (WA) and / or
- Central Retroplacental hematoma (RPH) history < 34 WA and / or
- History of severe preeclampsia < 34 WA and
- Informed consent, written and obtained
Who cannot join
- Age <18 years or
- Age > 45 years or
- Multiple pregnancy or
- Pregnancy > 7 WA or
- Positive immunological assessment or
- Known history of Thromboembolic diseases, Hemorrhagic diseases, Systemic Lupus Erythematosus (SLE), Heparin-induced thrombocythemia (HIT), Suspicion of thrombophilia (burdened history) or an episode of Deep Vein Thrombosis (DVT) or
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- Anticoagulation required or
- Thrombocythaemia < 100,000 plq / µl or
- Weight > 100 kg or
- Osteoporosis or
- Known allergy to the study products or
- Inability to ensure injections' administration or
- Family history of DVT before 40 years of age or
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Maternity Center of Wassila Bourguiba Hospital - Department A
Tunis
About this study
Official title: Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes
Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women.
Read the detailed description
Randomized, prospective, monocentric, open-label comparative study with two parallel groups (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in reducing placental insufficiency during pregnancy in pregnant women.
- Conditions
- Placental Insufficiency, Enoxaparin
- Being tested
- Enoxaparin 40 mg / 0.4 mL Prefilled Syringe, Aspirin 100 mg Oral Tablet, Enteric Coated
- Medical subject headings
- Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin 40 mg / 0.4 mL Prefilled SyringeDrug
Aspirin 100 mg Oral Tablet, Enteric CoatedDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients going on ASPIRIN 100 mg/day combined with ENOXAPARIN 4000 IU per dat prevention treatment according to randomization:
* Administer Aspirin 100 mg Oral Tablet, Enteric Coated once daily
* Administer the Enoxaparin preventive dose of 4000 IU as a subcutaneous Enoxaparin 40 mg / 0.4 mL Prefilled Syringe once daily
* Start treatment from inclusion visit
* Maintain treatment until the day of delivery, or the appearance of a complication (Retroplacental hematoma (RPH), preeclampsia (PE) , In utero fetal death (IUFD), or Intrauterine growth restriction (IUGR) and its complications) Receives: Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe; Drug: Aspirin 100 mg Oral Tablet, Enteric Coated |
| Arm 2 | Other | Patients going on ASPIRIN 100 mg/day prevention treatment alone according to randomization:
* Administer only Aspirin 100 mg Oral Tablet, Enteric Coated once daily
* Administer orally
* Start treatment from inclusion visit
* Maintain treatment until 35 Weeks of Amenorrhea (WA) Receives: Drug: Aspirin 100 mg Oral Tablet, Enteric Coated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of maternal death
To compare the incidence of maternal death between the two arms of the study.
Measured: 7 - 42 weeks of amenorrhea
Recurrence rate of preeclampsia
To compare the recurrence rate of preeclampsia between the two arms of the study.
Measured: 7 - 42 weeks of amenorrhea
Incidence of intrauterine growth restriction (IUGR)
To compare the incidence of IUGR between the two arms of the study.
Measured: 7 - 42 weeks of amenorrhea
Incidence of retroplacental hematoma (RPH)
To compare the incidence of RPH between the two arms of the study.
Measured: 7 - 42 weeks of amenorrhea
Incidence of perinatal death
To compare the incidence of perinatal death between the two arms of the study.
Measured: 7 - 42 weeks of amenorrhea
Secondary outcomes (4)
Incidence of miscarriage
To compare the incidence of miscarriage between the two arms of the study.
Measured: 13 - 21 weeks of amenorrhea
Incidence of in utero fetal death (IUFD)
To compare the incidence of IUFD between the two arms of the study.
Measured: 22 weeks of amenorrhea at birth
Incidence of neonatal death
To compare the incidence of neonatal death between the two arms of the study.
Measured: From birth to 28 days of life
Number of adverse events
To compare the safety of both study products
Measured: 7 - 42 weeks of amenorrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start23 Oct 2013
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental InsufficiencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dalenda Chelly, OB/GYN, Principal investigator, Wassila Bourguiba Hospital Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528967
- Sponsor's protocol ID
- EG01
- Acronym
- PRESANCE
- Status last verified
- Aug 2018
- First submitted
- 7 May 2018
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes
- ClinicalTrials.gov ID
- NCT03528967
- Acronym / sponsor ID
- PRESANCE / EG01
- Conditions
- Placental Insufficiency, Enoxaparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2013 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 18 May 2018 (actual)
- 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.
Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women.
Detailed description
Randomized, prospective, monocentric, open-label comparative study with two parallel groups (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in reducing placental insufficiency during pregnancy in pregnant women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe, Drug: Aspirin 100 mg Oral Tablet, Enteric CoatedPatients going on ASPIRIN 100 mg/day combined with ENOXAPARIN 4000 IU per dat prevention treatment according to randomization: * Administer Aspirin 100 mg Oral Tablet, Enteric Coated once daily * Administer the Enoxaparin preventive dose of 4000 IU as a subcutaneous Enoxaparin 40 mg / 0.4 mL Prefilled Syringe once daily * Start treatment from inclusion visit * Maintain treatment until the day of delivery, or the appearance of a complication (Retroplacental hematoma (RPH), preeclampsia (PE) , In utero fetal death (IUFD), or Intrauterine growth restriction (IUGR) and its complications) |
| Arm 2 | Other | Drug: Aspirin 100 mg Oral Tablet, Enteric CoatedPatients going on ASPIRIN 100 mg/day prevention treatment alone according to randomization: * Administer only Aspirin 100 mg Oral Tablet, Enteric Coated once daily * Administer orally * Start treatment from inclusion visit * Maintain treatment until 35 Weeks of Amenorrhea (WA) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and
- Age ≤ 45 years and
- Single and confirmed pregnancy and
- Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) < 3rd percentile and / or
- In utero fetal death (IUFD) history > 12 weeks of amenorrhea (WA) and / or
Key exclusion criteria (13 listed)
- Age <18 years or
- Age > 45 years or
- Multiple pregnancy or
- Pregnancy > 7 WA or
- Positive immunological assessment or
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 |
|---|---|---|
| Enoxaparin 40 mg / 0.4 mL Prefilled Syringe | Drug | Arm 1 |
| Aspirin 100 mg Oral Tablet, Enteric Coated | Drug | Arm 1, Arm 2 |
Primary outcome
Incidence of maternal death
Time frame: 7 - 42 weeks of amenorrhea
To compare the incidence of maternal death between the two arms of the study.
Recurrence rate of preeclampsia
Time frame: 7 - 42 weeks of amenorrhea
To compare the recurrence rate of preeclampsia between the two arms of the study.
Incidence of intrauterine growth restriction (IUGR)
Time frame: 7 - 42 weeks of amenorrhea
To compare the incidence of IUGR between the two arms of the study.
Incidence of retroplacental hematoma (RPH)
Time frame: 7 - 42 weeks of amenorrhea
To compare the incidence of RPH between the two arms of the study.
Incidence of perinatal death
Time frame: 7 - 42 weeks of amenorrhea
To compare the incidence of perinatal death between the two arms of the study.
4 secondary outcomes
Incidence of miscarriage
Time frame: 13 - 21 weeks of amenorrhea
Incidence of in utero fetal death (IUFD)
Time frame: 22 weeks of amenorrhea at birth
Incidence of neonatal death
Time frame: From birth to 28 days of life
Number of adverse events
Time frame: 7 - 42 weeks of amenorrhea
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 2 Jul 2020.
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Fetal Growth Restriction, Placental Insufficiency
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.
Dalenda Chelly, OB/GYN principal investigator
Wassila Bourguiba Hospital Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin 40 mg / 0.4 mL Prefilled Syringe and Aspirin 100 mg Oral Tablet, Enteric Coated in people with Placental Insufficiency and Enoxaparin, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of maternal death (time frame: 7 - 42 weeks of amenorrhea). The study lists 5 primary outcomes in all. 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 2 Jul 2020.