ow dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour – the APRIL study

Phase 1

• Conditions: Prevention of recurrent spontaneous preterm birth; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-003220-31-NL
• Lead Sponsor: VU medical center, Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-16
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 406

Inclusion Criteria

Pregnant women: >18 years old on inclusion, with a history of spontaneous preterm birth.

Spontaneous preterm birth is defined as: birth following spontaneous contractions with intact membranes or birth after preterm ruptured membranes at a gestational age between 22 and 37 weeks. .

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 406
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of Indicated PTB for maternal reasons such as preeclampsia or HELLP
- History of indicated PTB fetal reasons such as IUGR
- Fetal abnormalities
- Multiple pregnancy either in index or current pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified