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Time to Delivery of Preterm Birth

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ClinicalTrials.gov Identifier: NCT02853656
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals NHS Foundation Trust

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.


Condition or disease
Pre Term 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.

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Study Type : Observational
Estimated Enrollment : 242 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Time to Delivery of Preterm Birth
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020



Primary Outcome Measures :
  1. diagnosis of heightened risk of imminent delivery [ Time Frame: 7 days ]
    preterm birth at 7 days

  2. diagnosis of heightened risk of imminent delivery [ Time Frame: 14 days ]
    preterm birth at 14 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women with singleton pregnancy between 22-34 weeks gestation with signs and symptoms of pre term birth
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853656


Contacts
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Contact: Donna M Southam, BSc, MSc 01268 524900 Donna.Southam@btuh.nhs.uk
Contact: Carol L Alves, BSc, MRes 01268 524900 ext 3599 Carol.Alves@btuh.nhs.uk

Locations
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United Kingdom
Basildon and Thurrock University Hospitals NHS FT Recruiting
Basildon, Essex, United Kingdom, SS16 5NL
Contact: Donna M Southam, BSc, MSc    01268 529400    Donna.Southam@btuh.nhs.uk   
Contact: Carol L Alves, BSc, MRes    01268 524900 ext 3599    Carol.Alves@btuh.nhs.uk   
Principal Investigator: Donna M Southam, BSc, MSc         
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Investigators
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Study Director: Amaju Ikomi, MBBS FRCOG Basildon and Thurrock University Hospitals NHS FT
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Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02853656    
Other Study ID Numbers: B868
194502 ( Other Identifier: IRAS ID )
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
preterm birth
gestation
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications