Clinical Grade MIS Device for Cervical Assessment to Predict Preterm Birth

NCT04008485 | Completed

• 1 other identifier: STH19385
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (2)

• Cervical Resistivity

  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.

  Week 20-22 of pregnancy

• Cervical Resistivity

  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.

  Week 26-28 of pregnancy

Secondary Outcomes (2)

• Assess service-user acceptability of the MIS device

  Within 1 month of week 26-28 visit

• Cost-effectiveness

  At 24 months

Study Arms (2)

Asymptomatic high-risk women

EXPERIMENTAL

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

Symptomatic pregnant women

EXPERIMENTAL

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

Interventions

Magnetic Electric Impedance Spectroscopy Device to predict PTB DEVICE

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.

Asymptomatic high-risk women; Symptomatic pregnant women

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Jessop Wing Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dilly OC Anumba, Prof

  Honorary Consultant in Obstetrics and Gynaecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: July 5, 2019
• Study Start: May 1, 2018
• Primary Completion: June 29, 2021
• Study Completion: October 31, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

GB (1)