To assess the effectiveness of low dose aspirin compared with placebo in prevention of recurrent spontaneous preterm birth.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be premature delivery, defined as a GA < 37
weeks.
Secondary outcome
Secondary outcomes will be a composite poor neonatal outcome (including BPD,
PVL > grade 1, IVH > grade 2, NEC, ROP, culture
proven sepsis and perinatal death, number of days on ventilation support, days
of admission on the NICU, convulsions,
asphyxia, proven meningitis, pneumothorax and total days in hospital until 3
months corrected age. Furthermore preterm
delivery < 28 weeks, < 32 weeks, < 34 weeks of GA will be calculated, as well
as IUGR defined as birth weight < p10. Preterm
delivery will be analysed as spontaneous, induced or as a combination. Maternal
outcomes include maternal side effects
maternal mortality, maternal morbidity and major ante- or post-partum
haemorrhage.
Background summary
Recurrent spontaneous preterm birth is a major problem in obstetrics and
affects around 2500 pregnancies annually in the Netherlands. It has a great
impact on both patients and national healthcare.
Study objective
To assess the effectiveness of low dose aspirin compared with placebo in
prevention of recurrent spontaneous preterm birth.
Study design
Multicenter, randomized, double blinded, placebo controlled trial. Local
protocol for prevention of preterm labour can be followed alongside the study
protocol.
Intervention
Low dose aspirin (80mg) versus placebo, initiated from 8-16 week up to 36 weeks
of gestation.
Study burden and risks
This study will be the first to asses the effectiveness of aspirin on the
prevention of recurrent spontaneous preterm birth. Extensive research has
already been performed on the effectiveness of aspirin to prevent other
pregnancy complications such as preeclampsia and intrauterine growth
restriction. For the prevention of these pregnancy complications the
effectiveness has been established. The potential benefit of low dose aspirin
in this population will be prolongation of pregnancy duration and improvement
of neonatal outcome.
The potential risks are confined to mild discomfort in the epigastric region.
Aspirin is a safe intervention in pregnancy as a recent review commissioned by
the 'U.S. Preventive Services Task Force' concluded.
The burden en risk of participation are considered minimal.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-003220-31-NL |
| CCMO | NL54463.018.15 |