Costs and effects of fibronectin as a triage in women with threatened preterm labour.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005563-33-NL

Enrollment

220

Registered

2008-12-09

Start date

2009-10-22

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Preterm Labour MedDRA version: 9.1 Level: LLT Classification code 10036600 Term: Premature labour

Interventions

Trade Name: Nifedipine retard CF 20 mg tablets Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: number of days to delivery, truncated at 7 days;Secondary Objective: neonatal mortality neonatal morbidity maternal morbidity (side effects of tocolysis) costs health related quality of life;Primary end point(s): number of days to delivery truncated at 7 days after study entry	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026