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

NCT02301780 | Completed Phase 3 DMC

• 1 other identifier: 0066-14-RMC
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Number of participants with Pre-eclampsia requiring delivery prior to 37 weeks of gestation

  24-26 Weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Intervention Group

ACTIVE COMPARATOR

Aspirin

Drug: Aspirin

Interventions

Aspirin DRUG

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.

Intervention Group

Placebo DRUG

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.

Also known as: Aspirin

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• University College, London: collaborator

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: November 26, 2014
• Study Start: December 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 9, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)