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Clinical Grade MIS Device for Cervical Assessment to Predict Preterm Birth

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ClinicalTrials.gov Identifier: NCT04008485
Recruitment Status : Unknown
Verified July 2019 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:
Every year, globally, about 15 million babies are born preterm (before 37 weeks). This number is rising. Preterm birth (PTB) complications are the leading cause of death among children under 5 years of age, responsible for nearly 1 million deaths annually. PTB poses a strain on scarce health resources: each very premature baby costs tens of thousands of pounds in newborn care. One in 4 babies born before 28 weeks develop neurological impairment, a parent often having to give up work to care for an affected child. The prediction and prevention of PTB remain challenging because current methods, such as measuring the cervix by ultrasound, have limited accuracy. If a technique that reliably predicts PTB could be developed, there are care measures that can be employed to delay birth to reduce long-term disability/impairment. The Investigators have been studying whether they can detect the changes in cervical tissue structure and composition that precede PTB by using very low current Electrical Impedance Spectroscopy (EIS). Evidence recently showed that women at high risk of PTB (history of previous PTB), who deliver preterm, including delivery before 28 weeks gestation, have lower cervical "resistance" in mid-pregnancy than those who deliver at term. With NIHR funding, the investigators have developed a new device, based on a technique called magnetic impedance spectroscopy (MIS) that should address limitations of the EIS device for assessing PTB risk. The investigators now want to refine the new MIS device by minimising the signals it receives from other tissues around the cervix and making its measurements at internal body temperature more stable. The researchers also conduct clinical experiments to test whether it predicts PTB better than the previous EIS device, and check whether pregnant women find its use acceptable. This information will allow them to obtain UK regulatory approval to test the device in larger trials.

Condition or disease Intervention/treatment Phase
Preterm Birth Device: Magnetic Electric Impedance Spectroscopy Device to predict PTB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Developing and Testing a Clinical Grade Magnetic Impedance Spectroscopy Device for Cervical Assessment to Predict Preterm Birth
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
Experimental: Asymptomatic high-risk women
Women will be scheduled to attend for MIS measurement at 20-22 weeks, to be repeated at 26-28 weeks. This measurement will be taken at the same time as the routine examination which they receive when they attend the prematurity clinic. At each study visit the patient will undergo a vaginal examination. Triple high vaginal swabs will then be taken for bacteriology and fetal fibronectin. The sterile magnetic impedance probe will then be introduced, data being captured automatically by pressing the data capture button on the handle of the device. A transvaginal scan will also be performed to measure CL.
Device: Magnetic Electric Impedance Spectroscopy Device to predict PTB
During this phase, we will measure MIS in 100 women at high risk of PTB (Group 1) and 100 women with symptoms of PTB to confirm its predictive potential for PTB. To determine whether MIS assessment could prove a platform technique for other tests and treatments within existing antenatal care pathways for PTB, we will also assess vaginal swabs for fFN and measure cervical length (CL) by ultrasound.

Experimental: Symptomatic pregnant women
These women (≥ 16 years of age) will be approached when they attend the labour delivery room or triage with symptoms of preterm labour as detailed above. As a matter of clinical routine these women receive a speculum examination, triple vaginal swabs taken, and fetal fibronectin and cervical length scans as indicated. The study will be explained to them and study materials provided. They will be asked to contact research staff by telephone or through their clinical midwife if they wish to participate. They will be given time to decide. If they agree to take part, written informed consent will then be obtained by research staff who will also conduct the MIS study. If clinical assessments have not already been performed by the time of obtaining consent they will be carried out at the same time
Device: Magnetic Electric Impedance Spectroscopy Device to predict PTB
During this phase, we will measure MIS in 100 women at high risk of PTB (Group 1) and 100 women with symptoms of PTB to confirm its predictive potential for PTB. To determine whether MIS assessment could prove a platform technique for other tests and treatments within existing antenatal care pathways for PTB, we will also assess vaginal swabs for fFN and measure cervical length (CL) by ultrasound.




Primary Outcome Measures :
  1. Cervical Resistivity [ Time Frame: Week 20-22 of pregnancy ]
    Cervical resistivity measured by use of Magnetic Impedance Spectroscopy probe. Probe measurements will be compared against birth outcomes to determine predictive ability of probe for pre-term birth.

  2. Cervical Resistivity [ Time Frame: Week 26-28 of pregnancy ]
    Cervical resistivity measured by use of Magnetic Impedance Spectroscopy probe. Probe measurements will be compared against birth outcomes to determine predictive ability of probe for pre-term birth. Measuring changes from week 20-22 visit.


Secondary Outcome Measures :
  1. Assess service-user acceptability of the MIS device [ Time Frame: Within 1 month of week 26-28 visit ]

    Assess service-user acceptability of the MIS device for screening for preterm birth, previously confirmed to be good for EIS in qualitative studies using the Sheffield Mark V EIS device.

    Questionnaires administered to capture participant acceptability


  2. Cost-effectiveness [ Time Frame: At 24 months ]
    On the basis of our clinical observations update our previously-developed cost-effectiveness model of such a device for predicting PTB, and estimate the maximum price that allows the technology to be cost-effective using the "headroom" approach. All data to be captured and analysed by health economists at clinical trials unit.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 16 years of age
  • no signs of cervical infection
  • no previous cervical surgery
  • had a normal cervical smear within the previous 3 years
  • identified as asymptomatic high-risk antenatally (Asymptomatic high-risk women participants)
  • Symptoms of preterm labour (Symptomatic Pregnant women participants)

Exclusion Criteria:

  • < 16 years of age
  • signs of cervical infection
  • previous cervical surgery
  • no cervical smear within previous 3 years
  • not identified as symptomatic high-risk antenatally (Asymptomatic high-risk women participants)
  • No symptoms of preterm labour (Symptomatic Pregnant women participants)

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): NCT04008485


Contacts
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Contact: Dilly OC Anumba, Prof +44 114 2159707 d.o.c.anumba@sheffield.ac.uk
Contact: Thomas Almond thomas.almond@sth.nhs.uk

Locations
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United Kingdom
Jessop Wing Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Dilly Anumba         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Investigators
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Principal Investigator: Dilly OC Anumba, Prof Honorary Consultant in Obstetrics and Gynaecology
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04008485    
Other Study ID Numbers: STH19385
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications