The objective was to assess the effectiveness of low-dose aspirin in the prevention of recurrent preterm birth.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
pregnancy, recurrent preterm birth, recurrent preterm labour, pretem birth, preterm labour, PTB, prevention, aspirin, ASA zwangerschap, herhaalde vroeggeboorte, vroeggeboorte, preventie, aspirine
Research involving
Sponsors and support
Intervention
- Medicine
Outcome measures
Primary outcome
Preterm birth, defined as birth at a gestational age less than 37 weeks.
Secondary outcome
Composite of poor neonatal outcome, the individual components of the composite perinatal outcome, number of days on ventilation support (ventilation and /or respiratory support by Continuous Positive Airway Pressure (CPAP)), infant respiratory distress syndrome (IRDS) that requires treatment with surfactant, patent ductus arteriosus (PDA) that requires treatment, cerebellar bleeding, days of admission on the NICU, convulsions, asphyxia, proven meningitis, pneumothorax and total days in hospital until 3 months corrected age.
Maternal outcomes; maternal side effects, maternal mortality, hospital admissions, maternal morbidity, placental abruption, maternal infection or inflammation, major ante- or post-partum haemorrhage. Subgroup analyses will be performed for women with a previous preterm birth before and after 30 and 34 weeks GA, contractions with intact membranes versus PPROM, women treated with progestagens versus no additional treatment, women with a short cervix ( < 25 mm) in the current pregnancy and women initiating low dose ASA < 12 weeks versus 12-16 weeks of gestation.
Background summary
Preterm birth is the leading cause of neonatal morbidity and mortality. The recurrence rate of spontaneous preterm birth is high and additional preventive measures are required.
Study objective
The objective was to assess the effectiveness of low-dose aspirin in the prevention of recurrent preterm birth.
Study design
We performed a multicentre, double-blind, placebo-controlled, randomised trial in 8 tertiary and 26 secondary care hospitals in the Netherlands. We recruited women with a singleton pregnancy and a history of spontaneous preterm birth of a singleton between 22 and 37 weeks of gestation. Participants were randomly assigned to daily aspirin (80 mg) or placebo initiated between 8 and 16 weeks of gestation and continued until 36 weeks or delivery. The primary outcome was preterm birth before 37 weeks of gestation. We performed analyses by intention-to-treat. For the primary outcome, we performed a pre-specified sensitivity analysis including women with ≥80% compliance with medication. The trial was registered in the Dutch Trial Register (NTR5675, NL5553). <
Intervention
Low-dose aspirin (80 mg)
Anadeijda J.E.M.C. Landman
Meibergdreef 9
1105 AZ
Amsterdam
Netherlands
a.landman@amsterdamumc.nl
Anadeijda J.E.M.C. Landman
Meibergdreef 9
1105 AZ
Amsterdam
[default]
The Netherlands
a.landman@amsterdamumc.nl
Age
Inclusion criteria
- Pregnant women
- >18 years of age
- 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)
Exclusion criteria
- Other indication for aspirin during pregnancy
- History of Indicated PTB for maternal reasons such as preeclampsia or HELLP
- History of indicated PTB for fetal reasons such as IUGR
- Fetal abnormalities in current pregnancy
- Multiple pregnancy either in the prior preterm birth pregnancy or current pregnancy
- Thrombocytopenia, thrombocytopathy
- Indications for the use of anticoagulants
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL5553 |
| NTR-old | NTR5675 |
| Other | 54463 : ABR |