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Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labour

Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labour

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21335
Enrollment
400
Registered
2008-06-03
Start date
2008-03-27
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sustained tocolysis, premature labour verlengde tocolyse, partus prematurus

Interventions

Patients will be randomly allocated to nifedipine or placebo for 12 days

Sponsors

UMCN St Radboud, Nijmegen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age between 26 and 32 weeks 2. Diagnosis of preterm birth 3. Treatment with tocolysis according to local protocol for 48 hours 4. Completed course of corticosteroids

Exclusion criteria

Exclusion criteria: 1. Signs of intrauterine infection 2. Signs of fetal distress 3. Maternal disease (ie. severe preeclampsia, HELLP syndrome)

Design outcomes

Primary

MeasureTime frame
- Neonatal mortality - Composite neonatal morbidity (ie. chronic lung disease, severe intraventricular hemorrhage more than grade 2, periventricular leucomalacia more than grade 1, proven sepsis, necrotising enterocolitis)

Secondary

MeasureTime frame
- Gestational age at delivery - Birth weight - Number of days in neonatal intensive care - Number of days on supported ventilation - Number of days on additional oxygen - Total days in hospital until 3 months corrected age - Economic analysis

Contacts

Public ContactC. Roos

UMCN St Radboud Nijmegen Department of Obstetrics/ Gynaecology Postbus 9101

c.roos@obgyn.umcn.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)