Can a test of preterm labour (quantitative fetal fibronectin) help diagnosis and clinical decision making?
- Conditions
- Preterm labourPregnancy and Childbirth
- Registration Number
- ISRCTN41598423
- Lead Sponsor
- niversity of Edinburgh and NHS Lothian ACCORD
- Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29674373 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31395241 Qualitative results (added 12/08/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34228732/ Development and validation of a risk prediction model (added 30/07/2021) 2021 Funder report results in https://pubmed.ncbi.nlm.nih.gov/34498576/ (added 10/09/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 2924
1. Women with signs and symptoms of preterm labour 24-34 weeks (or earlier gestation if the fetus is considered potentially viable) in whom hospital admission, inter-hospital transfer or treatment (antenatal steroids, tocolysis or magnesium sulphate) is being considered
2. Signs and symptoms may include any or all of the following:
2.1. Back pain
2.2. Abdominal cramping
2.3. Abdominal pain
2.4. Light vaginal bleeding
2.5. Vaginal pressure
2.6. Uterine tightenings or contractions
2.7. Cervical effacement or dilatation
1. Women who have moderate or severe vaginal bleeding
2. Women who have cervical dilatation greater or equal to 3cm
3. Women with confirmed rupture of membranes
4. Sexual intercourse, vaginal examination or transvaginal ultrasound in the preceding 24 hours factors can invalidate results and so these women will be initially excluded from the study. They can later be included if still symptomatic after 24 hours, when fFN accuracy will be restored
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method