Abstract
BackgroundAt present, women with threatened preterm labor before 32 weeks of gestation are, after transfer to a perinatal center, treated with tocolytics and corticosteroids. Many of these women are treated unnecessarily. Fibronectin is an accurate predictor for the occurrence of preterm birth among women with threatened preterm labor. We will assess whether triage of these women with fibronectin testing, cervical length or their combination is cost-effective.Methods/DesignWe will investigate a prospective cohort of women referred to a perinatal centre for spontaneous threatened preterm labor between 24 and 34 weeks with intact membranes. All women will be tested for fibronectin and cervical length. Women with a cervical length <10 mm and women with a cervical length between 10-30 mm in combination with a positive fibronectin test will be treated with tocolytics according to local protocol. Women with a cervical length between 10-30 mm in combination with a negative fibronectin test will be randomised between treatment with nifedipine (intervention) and placebo (control) for 48 hours. Women with a cervical length > 30 mm will be managed according to local protocol. Corticosteroids may be given to all women at the discretion of the attending physician. Primary outcome measure will be delivery within 7 days. Secondary outcome measures will be neonatal morbidity and mortality, complications of tocolytics, costs and health related quality of life. The analysis will be according to the intention to treat principle. We anticipate the probability on preterm birth within 7 days in the group of women with a negative fibronectine test to be 5%. Two groups of 110 women will be needed to assure that in case of non-inferiority the difference in the proportion of preterm deliveries < 7 days will be within a prespecified boundary of 7.5% (one sided test, β 0.2, α 0.05). Data obtained from women with a positive and negative fibronectin tests in both the cohort study and the trial will be integrated in a cost-effectiveness analysis that will assess economic consequences of the use of fibronectin.DiscussionThis study will provide evidence for the use of fibronectin testing as safe and cost-effective method in a triage for threatened preterm labor.Trial registrationNederlands Trial Register (NTR) number 1857, .
Highlights
At present, women with threatened preterm labor before 32 weeks of gestation are, after transfer to a perinatal center, treated with tocolytics and corticosteroids
Discriminating those women who will deliver preterm is difficult: about half of the women treated with tocolytics and/or corticosteroids do not deliver within a short time after the occurrence of symptoms
Of the remaining 75% of the women, less than 5% delivered within 7 days. These results are comparable with our pilot study of Wilms et al Amongst 19 women with a cervical length between 10-30 mm and a negative fibronectin test, only 1 woman delivered within 7 days[25]
Summary
Preterm birth is the most frequent cause of perinatal mortality and severe perinatal morbidity in the Western world [1]. Honest and co-workers published in 2002 a systematic review on the predictive capacity of fibronectin for preterm delivery [16] They identified 40 studies reporting on symptomatic women. This test is shown to predict preterm delivery in asymptomatic women at 20 weeks [22]. Of the remaining 75% of the women, less than 5% delivered within 7 days These results are comparable with our pilot study of Wilms et al Amongst 19 women with a cervical length between 10-30 mm and a negative fibronectin test, only 1 woman delivered within 7 days[25]. We will evaluate if adding fibronectin testing to cervical length measurement is a safe and cost-effective strategy as a triage for women with threatened preterm labor
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