Time to Delivery of Preterm Birth

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.

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

• Study Contact: Name: Donna M Southam, BSc, MSc; Phone Number: 01268 524900; Email: Donna.Southam@btuh.nhs.uk
• Study Contact Backup: Name: Carol L Alves, BSc, MRes; Phone Number: 3599 01268 524900; Email: Carol.Alves@btuh.nhs.uk

Study Locations

• United Kingdom
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • Basildon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of heightened risk of imminent delivery	preterm birth at 7 days	7 days
diagnosis of heightened risk of imminent delivery	preterm birth at 14 days	14 days

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Investigators: Study Director: Amaju Ikomi, MBBS FRCOG, Basildon and Thurrock University Hospitals NHS FT

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimated): August 3, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: preterm birth; gestation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: B868; 194502 (Other Identifier: IRAS ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO