Clinical trial NCT02853656: Time to Delivery of Preterm Birth
Official title: Time to Delivery of Preterm Birth
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pre Term Birth
Keywords: preterm birth
gestation
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with singleton pregnancy between 22-34 weeks gestation with signs and symptoms of pre term birth

Brief summary: Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; 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.

Detailed description: Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; 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.

Eligibility criteria: Inclusion criteria

* aged ≥ 18 years
* confirmed pregnancy
* gestational age between 22 and 34 weeks
* self-reported signs, symptoms or complaints suggestive of preterm labour;

  * abdominal pain
  * contractions
  * pelvic pressure

Exclusion criteria

* unable to provide written informed consent
* multiple pregnancy
* participating in an interventional clinical trial
* a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
* contraindicated to either fFN or PhIGFBP-1; e.g.

  * vaginal bleeding
  * cervical dilation ≥3cm dilated
  * evidence of rupture of membranes
  * had intercourse in last 24 hours
  * cervical cerclage in situ
  * placenta praevia

Primary outcomes:
measure: diagnosis of heightened risk of imminent delivery
timeFrame: 7 days
measure: diagnosis of heightened risk of imminent delivery
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon Hospital
state: Essex
Study officials:
affiliation: Basildon and Thurrock University Hospitals NHS FT
name: Amaju Ikomi, MBBS FRCOG
role: STUDY_DIRECTOR
References: