Clinical Grade MIS Device for Cervical Assessment to Predict Preterm Birth

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

Interventions

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.

Sponsors & Collaborators

• University of Sheffield

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Dilly OC Anumba, Prof · Honorary Consultant in Obstetrics and Gynaecology

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-01

Primary Completion

2021-06-29

Completion

2021-10-31

Countries

• United Kingdom

Study Locations