Trial of Early Screening Test for Pre-eclampsia and Growth Restriction

NCT03674606 | Completed Phase 4 DMC

• 3 other identifiers: TEST_PILOT_V12013-004241-17ISRCTN15191778
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 2

Brief Summary

A study of aspirin use in pregnancy to prevent high blood pressure and growth restriction of the fetus

Conditions

Pre-Eclampsia; Placenta Diseases; Eclampsia Preeclampsia; Fetal Growth Retardation; Foetal Growth Restriction

Keywords

Pre-eclampsia; Fetal Medicine Foundation; FMF screening; First trimester; Aspirin; Placental disease; nulliparous; LDA; low-dose aspirin; fetal growth restriction; trans-abdominal uterine artery doppler examination

Outcome Measures

Primary Outcomes (7)

• The proportion of eligible women that agree to participate in the study

  The proportion of eligible women that agree to participate in the study - this will be reflected as a proportion of the number of women approached at the screening stage (feasibility)

  Throughout study completion, less than 40 weeks

• Adherence to aspirin if prescribed

  Rate of adherence among study subjects prescribed aspirin.

  36 weeks

• The proportion of study subjects in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination

  This outcome includes the subjectively recorded ease of acquisition (feasibility).

  36 weeks

• The proportion of study subjects with a completed screening test who are issued the screening result within one week of having the test performed

  This includes the number of women within the screen and treatment group that went beyond 16-weeks before receiving the screening test result as beyond this time LDA may not be effective (feasibility).

  1 week

• Attendance at study visits

  Rate of attendance of study visits by study subjects

  36 weeks

• Satisfactory collection of all endpoints and variables

  Proportion of study subjects on which data for all other endpoints can be collected

  36 weeks

• Any specific study protocol violations

  Proportion of study subjects for which protocol violations are recorded

  36 weeks

Secondary Outcomes (8)

• The rate of pre-eclampsia as defined by the International Society for the Study of Pre-eclampsia in Pregnancy.

  Childbirth

• The rate of fetal growth restriction.

  Childbirth

• Spontaneous or iatrogenic delivery.

  Prior to 34 and 37 completed weeks of gestation

• Rate of admission to the neonatal intensive care unit.

  Childbirth

• Patient acceptability: ease of swallowing medication proportioned between categories of a 5-point Likert scale from "strongly agree" to "strongly disagree"

  20--22 weeks

Study Arms (3)

Routine low-dose aspirin

EXPERIMENTAL

Subjects shall receive standard antenatal care as well as taking oral low-dose aspirin from the eligibility visit until 36-week gestation once daily, as prescribed by the research clinician. Fetal Medicine Foundation screening test results from the recruitment visit shall not be disclosed to the participants in this arm.

Drug: Low dose aspirin

No aspirin

NO INTERVENTION

No low-dose aspirin will be prescribed. Fetal Medicine Foundation screening test results from the recruitment visit shall not be disclosed to the participants in this arm.

Test-indicated low-dose aspirin

ACTIVE COMPARATOR

The Fetal Medicine Foundation screening test will be used to determine whether a subject is at high risk of developing any pre-eclampsia until 42-week gestation. Participants with risk \> 1:8 must start low-dose aspirin treatment immediately. Participants with a risk \< 1:8 will be excluded.

Drug: Low dose aspirin

Interventions

Low dose aspirin DRUG

One 75 mg aspirin dose taken daily

Also known as: Nu-Seals 75, 75 mg aspirin

Routine low-dose aspirin; Test-indicated low-dose aspirin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility will be assessed based on first pregnancy status.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous women.
• Ability to speak and .read English
• Singleton pregnancy at \<14 weeks.
• Willing to sign voluntarily a statement of informed consent to participate in the study.

You may not qualify if:

• Presence of fetal anomaly at the time of the first trimester scan
• Women with known major risk factors for pre-eclampsia who should already be on Aspirin as per National Institute of Clinical Excellence (NICE) guidance; specifically chronic hypertension, underlying connective tissue, renal or vascular disorder, type 1 diabetes mellitus.
• Under 18 years of age.
• Currently enrolled in other clinical trials.
• Contraindications to Aspirin therapy.

Sponsors & Collaborators

• University College Dublin: lead
• Perinatal Ireland: collaborator
• National Maternity Hospital, Ireland: collaborator
• Royal College of Surgeons, Ireland: collaborator

Study Sites (2)

National Maternity Hospital

Dublin, Ireland

Location

Rotunda Hospital

Dublin, Ireland

Location

Related Publications (1)

• Mone F, Mulcahy C, McParland P, Stanton A, Culliton M, Downey P, McCormack D, Tully E, Dicker P, Breathnach F, Malone FD, McAuliffe FM. An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and growth restriction (TEST): Trial protocol. Contemp Clin Trials. 2016 Jul;49:143-8. doi: 10.1016/j.cct.2016.07.003. Epub 2016 Jul 6.

  PMID: 27394381 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Placenta Diseases; Fetal Growth Retardation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-armed parallel, multi-center, open-label randomised control trial

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: September 17, 2018
• Study Start: February 1, 2014
• Primary Completion: April 13, 2016
• Study Completion: April 13, 2016
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

IE (2)