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Trial record 31 of 481 for:    aspirin AND prevention

Combined Multi-marker Screening and Treatment With Aspirin for Pre-eclampsia Prevention (ASPRE)

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ClinicalTrials.gov Identifier: NCT02301780
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
Phase III two arm double-blinded randomised controlled trial to examine the effect of prophylactic low-dose aspirin from the first-trimester of pregnancy in women at increased risk for PET on the incidence and severity of the disease

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Aspirin Drug: Placebo Phase 3

Detailed Description:

Screening and Prevention of Pre-eclampsia (High Blood Pressure): Randomised Trial of Aspirin Versus Placebo (ASPRE)

Screening: All women with singleton pregnancies undergoing routine screening for aneuploidies will be invited to participate in the screening study for PET.

Interventions: Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.

The maximum duration for aspirin or placebo intake will be 180 days.

Key Inclusion and Exclusion Criteria Inclusion criteria for participant selection for RCT Age > 18 years, Singleton pregnancies, Live fetus at 11-13 weeks of gestation, High-risk for preterm-PET at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (pregnancy associated plasma protein-A and placental growth factor), English, Italian, Spanish, French, Dutch or Greek speaking (otherwise interpreters will be used), Informed and written consent.

Exclusion criteria Multiple pregnancies, Women taking low-dose aspirin regularly (administration must have ceased >28days prior to randomisation), Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment, Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness, Bleeding disorders such as Von Willebrand's disease, Peptic ulceration, Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication, Age < 18 years, Concurrent participation in another drug trial or at any time within the previous 28 days, Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Combined Multi-marker Screening and Randomised Patient Treatment With Aspirin for Evidence-based Pre-eclampsia Prevention. University College London - Sponsor of All EU Study Sites.
Study Start Date : December 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control Group
Placebo
Drug: Placebo

Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.

The maximum duration for aspirin or placebo intake will be 180 days.

Other Name: Aspirin
Active Comparator: Intervention Group
Aspirin
Drug: Aspirin

Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.

The maximum duration for aspirin or placebo intake will be 180 days.




Primary Outcome Measures :
  1. Number of participants with Pre-eclampsia requiring delivery prior to 37 weeks of gestation [ Time Frame: 24-26 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Singleton pregnancies
  • Live fetus at 11-13 weeks of gestation,
  • High-risk for preterm-PET at 11-13 weeks by the algorithm combining maternal history and characteristics, biophysical findings (mean arterial pressure and uterine artery Dopplers) and biochemical factors (pregnancy associated plasma protein-A and placental growth factor),
  • English, Italian, Spanish, French, Flemish, Hebrew, Arabic and Russian speaking (otherwise interpreters will be used)
  • Informed and written consent.

Exclusion Criteria:

  • Multiple pregnancies
  • Women taking low-dose aspirin regularly
  • Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
  • Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness, Bleeding disorders such as Von Willebrand's disease
  • Peptic ulceration
  • Hypersensitivity to aspirin or already on long term nonsteroidal anti- inflammatory medication
  • Age < 18 years
  • Concurrent participation in another drug trial or at any time within the previous 28 days
  • Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301780


Locations
Israel
Rabin Medical Center
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
University College, London

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02301780     History of Changes
Other Study ID Numbers: 0066-14-RMC
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Aspirin
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics