Aspirin for the prevention of spontaneous preterm birth

Phase 3

Completed

• Conditions: <p>pregnancy, recurrent preterm birth, recurrent preterm labour, pretem birth, preterm labour, PTB, prevention, aspirin, ASA zwangerschap, herhaalde vroeggeboorte, vroeggeboorte, preventie, aspirine</p>; preterm delivery, prematurity; 10010273

• Registration Number: NL-OMON29647
• Lead Sponsor: VU medical center Amsterdam

Brief Summary

From 31 May 2016 to 13 June 2019, 406 women were randomised of which 387 were included in the analysis: 194 women were allocated to aspirin and 193 to placebo. Preterm birth <37 weeks occurred in 41 (21.2%) women in the aspirin group and 49 (25.4%) in the placebo group (RRR 0.83, 95% CI 0.58 to 1.20, p=0.323). In women who were =80% compliant with medication, preterm birth occurred in 19.2% versus 24.8% (RRR 0.77, 95% CI 0.48 to 1.25, p=0.291). There was significant effect modification by gestational age of the previous preterm birth (interaction term p=0.042), with women with a previous preterm birth <30 weeks of gestation (RRR 0.59, 95% CI 0.23 to 1.02, p=0.059) having more benefit from aspirin than those with a previous preterm birth =30 weeks. The rate of poor neonatal outcome was 4.6% versus 2.6% (RRR 1.79, 95% CI 0.61 to 5.25, p=0.288).

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-02-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 406

Inclusion Criteria

- Pregnant women

- >18 years of age

Exclusion Criteria

- Other indication for aspirin during pregnancy

- History of Indicated PTB for maternal reasons such as preeclampsia or HELLP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Preterm birth, defined as birth at a gestational age less than 37 weeks.</p><br>