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


- candidate number6011
- NTR NumberNTR1857
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2009
- Secondary IDsZonMW 80-82310-98-09056
- Public TitleCosts and effects of fibronectin as a triage in women with threatened preterm labour.
- Scientific TitleAlleviation of Pregnancy Outcome by Suspending of Tocolysis in Early Labour.
- ACRONYMAPOSTEL I
- hypothesisFibronectin testing as a triage for women with threatened preterm labor is a cost effective strategy.
- Healt Condition(s) or Problem(s) studiedPrematurity, Nifedipine, Tocolysis, Fibronectin
- Inclusion criteria1. Gestational age between 24 and 34 weeks;
2. Symptoms of preterm labor;
3. Cervical length between 10-30 mm;
4. Intact membranes.
- Exclusion criteria1. Dilation > 3cm;
2. Vaginal bleeding;
3. Signs of fetal distress that could lead to pregnancy termination;
4. Maternal disease (i.e. severe preeclampsia, HELLP syndrome) that could lead to pregnancy termination;
5. Previous treatment for threatened preterm labor in the current pregnancy;
6. Contra indications for nifedipine.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2009
- planned closingdate
- Target number of participants220
- InterventionsAll 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.
- Primary outcomeNumber of days to delivery truncated at 7 days.
- Secondary outcome1. Neonatal mortality;
2. Neonatal morbidity;
3. Maternal morbidity (side effects of tocolytics);
4. Costs;
5. Health related quality of life.
- TimepointsInterim analysis after inclusion of 200 patients.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Jolande Vis
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD24-jun-2009 - 6-okt-2009


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