Assessing the safety and effectiveness of tocolysis for preterm labour.

Conditions: Threatened preterm birthDreigende vroeggeboorte

Registration Number: NL-OMON25764

Lead Sponsor: Academic Medical CenterP.O. box 226601100 DD AmsterdamTel. 020 - 566 9111

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 1514

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>

Secondary Outcome Measures

Name	Time	Method
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.