This study will assess the capacity of quantitave fetal fibronectin testing as compared to or in addition of cervical length measurements and vaginal digital exams to predict preterm delivey in women with symptoms of preterm labour.
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delivery within 7 days.
Secondary outcome
Gestational age at delivery, birth weight, neonatal morbidity, neonatal
mortality.
Background summary
Fetal fibronectin is an accurate predictor for the occurrence of preterm birth
among women with threatened preterm labour. At present, the risk assessment for
imminent preterm delivery consists either of observation of the frequency of
contractions, vaginal examinations, cervical length measurements, and/or
qualitative fibronectin testing. Women who are thought to be at high risk are
treated with tocolytics and corticosteroids. The use of a quantitative
fibronectin test might be a cost-effective strategy to reduce unnecessary
treatment.
Study objective
This study will assess the capacity of quantitave fetal fibronectin testing as
compared to or in addition of cervical length measurements and vaginal digital
exams to predict preterm delivey in women with symptoms of preterm labour.
Study design
European multicenter prospective cohort study
Study burden and risks
NA
Postbus 22660
1100 DD Amsterdam
NL
Postbus 22660
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Gestational age between 24-34 weeks
- Primary complaints or symptoms indicating threatened preterm delivery
- Intact membranes
Exclusion criteria
- Triplets or more foetuses
- Contra-indication for tocolysis
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 |
|---|---|
| CCMO | NL39368.018.12 |