Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 23, 2014
First Posted Date  ICMJE November 26, 2014
Last Update Posted Date November 9, 2016
Study Start Date  ICMJE December 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
Number of participants with Pre-eclampsia requiring delivery prior to 37 weeks of gestation [ Time Frame: 24-26 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
Pre-eclampsia requiring delivery prior to 37 weeks of gestation [ Time Frame: 24-26 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Multi-marker Screening and Treatment With Aspirin for Pre-eclampsia Prevention
Official Title  ICMJE 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.
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Preeclampsia
Intervention  ICMJE
  • 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.

  • 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
Study Arms  ICMJE
  • Placebo Comparator: Control Group
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Intervention Group
    Aspirin
    Intervention: Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2014)
3000
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02301780
Other Study ID Numbers  ICMJE 0066-14-RMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE University College, London
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP