Costs and effects of fibronectin as a triage in women with threatened preterm labour.
- Conditions
- Preterm LabourMedDRA version: 9.1Level: LLTClassification code 10036600Term: Premature labour
- Registration Number
- EUCTR2008-005563-33-NL
- Lead Sponsor
- ZonMw
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 220
Inclusion Criteria
Pregnant women between 24 and 34 weeks of gestation, with a primary complaint of uterine contractions, and at least three contractions per 30 minutes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patients with vaginal bleeding, a cerclage, ruptured amniotic membranes, cervical dilatation more than 3 cm or previous treatment for preterm contractions, recent myocard infartion or unstable angina pectoris. hypertension, reasons for quick delivery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: number of days to delivery, truncated at 7 days;Secondary Objective: neonatal mortality<br>neonatal morbidity<br>maternal morbidity (side effects of tocolysis)<br>costs<br>health related quality of life;Primary end point(s): number of days to delivery truncated at 7 days after study entry
- Secondary Outcome Measures
Name Time Method