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

This study evaluates whether testing for fibronectin is a cost-effective strategy that prevents unnecessary treatment in women with threatened preterm labor. We will investigate a prospective cohort of women who are referred to a perinatal centre for spontaneous threatened preterm labor between 24 and 34 weeks with intact membranes. All women in the cohort will be tested for fibronectin and cervical length. High risk women with cervical length below 10 mm will be treated with tocolytics. Low risk women with a cervical length above 30 mm will be managed according to local protocol (tocolysis on discretion of physician). Woman with a negative fibronectin test and a cervical length between 10 and 30 mm will be randomised between nifedipine (intervention) and placebo (control) for 48 hours. The primary outcome measure will be delivery within 7 days. Secondary outcome measures will be neonatal morbidity and mortality, complications of tocolytics as well as costs.

Fibronectin testing as a triage for women with threatened preterm labor is a cost effective strategy.

Interim analysis after inclusion of 200 patients.

All patients will be tested for fibronectin and cervical length. Patients with a negative fibronectin test and a cervix between 10-30 mm will be randomly allocated to nifedipine or placebo for 2 days. Patients with a positive fibronectin test will be treated with tocolytics and followed in the cohort.