Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02853656 |
| Other study ID # |
B868 |
| Secondary ID |
194502 |
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2016 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Mid and South Essex NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of
pregnanciesÍž preterm birth can lead to complications for the baby.
When mothers are identified as being at risk of going into preterm birth (giving birth within
the next 14 days) there are several treatments available that may help reduce the likelihood
of complications for the baby. These treatments usually need to be started within 24 hours so
it is very important that diagnosing preterm labour in not only fast but accurate.
There are several methods commonly used within hospitals for diagnosing mothers who may be at
risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and
phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).
The purpose of this study is to compare the two tests to see which is more accurate at
predicting preterm birth.
Description:
Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of
pregnanciesÍž preterm birth can lead to complications for the baby.
When mothers are identified as being at risk of going into preterm birth (giving birth within
the next 14 days) there are several treatments available that may help reduce the likelihood
of complications for the baby. These treatments usually need to be started within 24 hours so
it is very important that diagnosing preterm labour in not only fast but accurate.
There are several methods commonly used within hospitals for diagnosing mothers who may be at
risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and
phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).
The purpose of this study is to compare the two tests to see which is more accurate at
predicting preterm birth.
This is a prospective comparative study of fFN (control) and PhIGFBP-1 test (comparator) for
women with singleton pregnancies between 22-34 weeks gestation presenting with self-reported
signs, symptoms or complaints suggestive of preterm labour.
Both tests will be done on every participant - the tests will be sequenced so that every 5
participants the fFN test is undertaken first and then the next cohort of 5 will have the
PhIGFBP-1 swab taken first. This is to remove any potential biases surrounding which test was
undertaken first. Data collection (case report forms (CRFs)) will clearly document which test
was performed 1st and 2nd.
