No registrations found.
ID
Source
Brief title
Health condition
Premature labor, Fibronectin, Cervical length measurement, Nifedipine, Tocolysis
Vroeggeboorte, Fibronectine, Cervixlengte, Nifedipine, Tocolyse.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of days to delivery truncated at 7 days.
Secondary outcome
1. Neonatal mortality;
2. Neonatal morbidity;
3. Maternal morbidity (side effects of tocolytics);
4. Costs;
5. Health related quality of life.
Background summary
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.
Study objective
Fibronectin testing as a triage for women with threatened preterm labor is a cost effective strategy.
Study design
Interim analysis after inclusion of 200 patients.
Intervention
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.
Inclusion criteria
1. Gestational age between 24 and 34 weeks;
2. Symptoms of preterm labor;
3. Cervical length between 10-30 mm;
4. Intact membranes.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1747 |
| NTR-old | NTR1857 |
| Other | 80-82310-98-09056 : ZonMW |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |