ow dose aspirin in the Prevention of Recurrent Spontaneous Preterm Labour

Phase 3

Completed

Conditions: prematurity
preterm birth
preterm labour
10028920

Registration Number: NL-OMON47921

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 406

Inclusion Criteria

Women with a singleton pregnancy with a previous spontaneous preterm birth (in a singleton pregnancy), defined as birth at a gestational age between 22 and 37 weeks

Exclusion Criteria

Women with a history of indicated preterm births for maternal reasons such as preeclampsia or HELLP and for fetal reasons such as intra uterine growth restriction.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be premature delivery, defined as a GA < 37<br /><br>weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be a composite poor neonatal outcome (including BPD,<br /><br>PVL > grade 1, IVH > grade 2, NEC, ROP, culture<br /><br>proven sepsis and perinatal death, number of days on ventilation support, days<br /><br>of admission on the NICU, convulsions,<br /><br>asphyxia, proven meningitis, pneumothorax and total days in hospital until 3<br /><br>months corrected age. Furthermore preterm<br /><br>delivery < 28 weeks, < 32 weeks, < 34 weeks of GA will be calculated, as well<br /><br>as IUGR defined as birth weight < p10. Preterm<br /><br>delivery will be analysed as spontaneous, induced or as a combination. Maternal<br /><br>outcomes include maternal side effects<br /><br>maternal mortality, maternal morbidity and major ante- or post-partum<br /><br>haemorrhage.</p><br>