No registrations found.
ID
Source
Brief title
Health condition
Threatened preterm birth
Dreigende vroeggeboorte
Sponsors and support
P.O. box 22660
1100 DD Amsterdam
Tel. 020 - 566 9111
Intervention
Outcome measures
Primary outcome
The primary outcome of the study will be a composite adverse perinatal outcome, consisting of bronchopulmonary dysplasia at 36 weeks postmenstrual age (PMA), periventricular leucomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis ¡Ý stage 2, retinopathy of prematurity > grade 2 or need for laser therapy, culture proven sepsis and perinatal death.
Secondary outcome
Birth within 48 hours, time to delivery, gestational age at delivery, birth weight, number of days on invasive mechanical ventilation, length of admission in NICU, asphyxia, meningitis, pneumothorax and mortality until 3 months corrected age, maternal infection, maternal side effects and costs.
Background summary
The Netherlands
Belgium
United Kingdom
Ireland
Study objective
The aim of this study is to investigate if tocolysis with atosiban in threatened preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.
Study design
Up until 3 months corrected age.
Intervention
Atosiban
Inclusion criteria
- Woman ≥ 18 years old
- Singleton or twin pregnancy
- Gestational age between 30 0/7 and 33 6/7 weeks
- Threatened preterm birth defined by regular uterine contractions and one of the following:
- Cervical length of < 15 mm or
- Cervical length of 15-30 mm and a positive fFn test (≥ 50 ng/mL) or in case of absence of cervical length
measurement in local protocol a positive Fibronectin test or Partus test
- Ruptured amniotic membranes
Exclusion criteria
- Previous treatment for threatened preterm birth with corticosteroids in current pregnancy
- Contra indication for tocolysis
- Signs of fetal distress
- Signs of intra uterine infection
- Fetal chromosomal or severe congenital abnormalities
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6469 |
| NTR-old | NTR6646 |
| CCMO | NL61439.018.17 |
| OMON | NL-OMON54673 |