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.
ID
Bron
Verkorte titel
Aandoening
Threatened preterm birth
Dreigende vroeggeboorte
Ondersteuning
P.O. box 22660
1100 DD Amsterdam
Tel. 020 - 566 9111
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
The Netherlands
Belgium
United Kingdom
Ireland
Doel van het onderzoek
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.
Onderzoeksopzet
Up until 3 months corrected age.
Onderzoeksproduct en/of interventie
Atosiban
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6469 |
| NTR-old | NTR6646 |
| CCMO | NL61439.018.17 |
| OMON | NL-OMON54673 |