Placental InsufficiencyPhase 2ASAPNCT01616615
Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
A Phase 2 study testing Aspirin in people with Placental Insufficiency, run by Sara Varea at 3 sites in Spain.
Trial summary
To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placental Insufficiency
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 3 sitesSpain
- Study dates
- Sep 2012to Apr 2015
- Phase
- Phase 2
- 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
- Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length 45-48mm)
- Single gestation
- Mean pulsatility index of the uterine arteries above the 95th percentile for our population
Who cannot join
- Pre-existing hypertension, renal or cardiovascular disease
- previous history of pre-eclampsia
- Pregestational diabetes
- Systemic lupus Erythematosus
- Gastric ulcer
- Acetylsalicylic acid or lactose hypersensitivity
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- Bleeding disorders
- Fetal disorders (including chromosomal abnormalities)
- Administration of low molecular weight heparin
- Concomitant treatment with aspirin
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Clinic of Barcelona
Barcelona, Barcelona, 08028
Institut Dexeus
Barcelona, Barcelona, 08028
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester
- Conditions
- Placental Insufficiency
- Being tested
- Aspirin, placebo
- Medical subject headings
- Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
150 mg/day oral use
placeboDrug
1 capsule / day oral use
| Study group | Role | What they receive |
|---|---|---|
| ASPIRIN | Experimental | 150 mg milligram(s)/ day oral use Receives: Drug: Aspirin |
| PLACEBO | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine artery mean pulsatility
Measured: at 28 weeks of gestation
Secondary outcomes (8)
Pre-eclampsia
pre-eclampsia defined as: diastolic blood pressure (DBP)> = 90 mmHg) or systolic (SBP)> = 140 mmHg on two separated determinations (> 4h) with proteinuria> 300 mg/24 h -Gestational age at debut of preeclampsia
Measured: delivery
Severe preeclampsia
Severe preeclampsia defined as: preeclampsia criteria + DBP> = 110 mmHg, proteinuria> 5g/24h, oligouria (<400 ml/24h), neurological symptoms (brain or visual), acute pulmonary edema (gasometric and radiological criteria), persistent epigastric pain, abnormal liver function (AST or Alanine aminotransferase(ALT)> 70 IU), analytical signs of hemolysis (LDH> 700 U / L) and / or thrombocytopenia (<100.000/ml).
Measured: at delivery
Intrauterine Growth Retardation
Intrauterine Growth Retardation: birth weight below the 10th percentile of our population + pulsatility index in umbilical artery in the third trimester (on two separate occasions >48h)above the 95th percentile.
Measured: at delivery
Significant neonatal morbidity
Significant neonatal morbidity (convulsions, intraventricular hemorrhage> grade III, periventricular leukomalacia, hypoxic-ischemic encephalopathy, abnormal electroencephalogram, necrotizing enterocolitis, acute renal failure (serum creatinine> 1.5 mg / dl) or heart failure (requiring inotropic agents
Measured: at delivery
number of cesarean
Emergent cesarean section due to fetal wellbeing loss Birth weight
Measured: at delivery
Neonatal acidosis
Neonatal acidosis (arterial pH <7.10 + Base excess(BE)> 12 milliequivalent (mEq) / L)
Measured: at delivery
Perinatal mortality
Perinatal mortality (> 22 weeks gestation, <28 days postpartum)
Measured: 28 days post partum
Days in the Neonatal Intensive Care Unit
Measured: 28 days post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionApr 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- FRANCESC FIGUERAS, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616615
- Sponsor's protocol ID
- ASAP
- Other IDs
- 2012-000622-22
- Acronym
- ASAP
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2012
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT01616615
- Acronym / sponsor ID
- ASAP / ASAP
- Conditions
- Placental Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Jun 2012 (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.
To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASPIRIN | Experimental | Drug: Aspirin150 mg milligram(s)/ day oral use |
| PLACEBO | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length 45-48mm)
- Single gestation
- Mean pulsatility index of the uterine arteries above the 95th percentile for our population
Key exclusion criteria (10 listed)
- Pre-existing hypertension, renal or cardiovascular disease
- previous history of pre-eclampsia
- Pregestational diabetes
- Systemic lupus Erythematosus
- Gastric ulcer
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 |
|---|---|---|
| Aspirin150 mg/day oral use | Drug | ASPIRIN |
| placebo1 capsule / day oral use | Drug | PLACEBO |
Primary outcome
Uterine artery mean pulsatility
Time frame: at 28 weeks of gestation
8 secondary outcomes
Pre-eclampsia
Time frame: delivery
Severe preeclampsia
Time frame: at delivery
Intrauterine Growth Retardation
Time frame: at delivery
Significant neonatal morbidity
Time frame: at delivery
number of cesarean
Time frame: at delivery
Neonatal acidosis
Time frame: at delivery
Perinatal mortality
Time frame: 28 days post partum
Days in the Neonatal Intensive Care Unit
Time frame: 28 days post partum
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 18 Aug 2015.
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Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
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The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
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Oxford Luteal Dysfunction and Placental Insufficiency Study
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Speckle Tracking Echocardiography as a Tool for Early Diagnosis of Impaired Fetal Growth Twin Pregnancies
Fetal Growth Restriction, Cardiac Remodeling, Ventricular
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Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction , and the Changes in Aortic Isthmus Doppler Parameters With Every Changes of Other Early Iugr Parameters Like EFW, Uterine Artery Doppler, Cerebroplacental Ratio and Ductus Venosus Doppler in Comparison With Normal Group .
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.
FRANCESC FIGUERAS, MD, PhD principal investigator
Hospital Clinic of Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with Placental Insufficiency, run by Sara Varea at 3 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 3 inclusion and 10 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 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Uterine artery mean pulsatility (time frame: at 28 weeks of gestation). 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 18 Aug 2015.