First Trimester Aspirin Trial

Phase 3

Completed

• Conditions: Pre-eclampsia; Pregnancy and Childbirth

• Registration Number: ISRCTN13633058
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-12
• Last Update Posted: 11 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1760

Inclusion Criteria

Current inclusion criteria as of 12/03/2013:
1. Aged 18 years or over
2. Singleton pregnancies
3. Live fetus at 11-13 weeks of gestation
4. High-risk for preterm pre-eclampsia will be defined 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 [PAPP-A] and placental growth factor [PlGF]).

Previous inclusion criteria until 12/03/2013:
All singleton pregnancies with a live foetus at 11+0 - 13+6 weeks of gestation.

Exclusion Criteria

Current exclusion criteria as of 28/04/2014:
1. Multiple pregnancies
2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
3. Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness
4. Bleeding disorders such as Von Willebrand?s disease
5. Peptic ulceration
6. Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication
7. Age < 18 years
8. Women taking low-dose aspirin regularly
9. Concurrent participation in another drug trial or at any time within the previous 28 days
10. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol

Exclusion criteria from 12/03/2013 to 28/04/2014:
1. Multiple pregnancies
2. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment
3. Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness
4. Bleeding disorders such as Von Willebrand?s disease
5. Peptic ulceration
6. Hypersensitivity to aspirin or already on long term non-steroidal anti-inflammatory medication
7. Age < 18 years

Original exclusion criteria until 12/03/2013:
1. Major foetal abnormalities identified at the 11+0 - 13+6 weeks assessment
2. Women who are unconscious or severely ill
3. Learning difficulties
4. Serious mental illness
5. Women with bleeding disorders
6. Peptic ulceration
7. Hypersensitivity to aspirin
8. Under the age of 18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified