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

Alleviation of Pregnancy Outcome by Suspending of Tocolysis in Early Labour.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27054

Enrollment

220

Registered

2009-06-24

Start date

2009-12-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Premature labor, Fibronectin, Cervical length measurement, Nifedipine, Tocolysis Vroeggeboorte, Fibronectine, Cervixlengte, Nifedipine, Tocolyse.

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Secondary

Measure	Time frame
1. Neonatal mortality; 2. Neonatal morbidity; 3. Maternal morbidity (side effects of tocolytics); 4. Costs; 5. Health related quality of life.	—

Primary

Measure	Time frame
Number of days to delivery truncated at 7 days.	—

Contacts

Public ContactJolande Vis

j.y.vis@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)