ECCLIPPx^TM - EleCtriCaL Impedance Prediction of Preterm birth by spectroscopy of the cerviX

ECCLIPPx^TM II is a new research project based in Sheffield which investigates the prediction of preterm birth. It follows the successful completion of ECCLIPPxTM I in 2016 and it is supported by NIHR i4i (IILB021620001).

Almost 8% of all births in the UK occur early before 37 weeks’ gestation. But the prediction and prevention of preterm birth remain challenging because current methods have limited accuracy. We therefore aim to assess whether new technologies can reliably identify women at high risk of premature delivery, so that we can offer them treatment to prolong pregnancy.

The Current Study:

Overview: approximately 8% of births in the UK occur early before reaching 37 weeks of gestation. Premature babies usually require specialist neonatal care and may need to stay in hospital for a prolonged period after birth. They are at risk of a variety of health problems and although the survival rates have improved, babies can still be left with lifelong complications. This has a huge impact on women and their families and on the healthcare services. It is therefore vital to try to predict and prevent preterm delivery if possible.

Before labour starts the neck of the womb (cervix) undergoes changes to prepare for birth. These changes include softening, shortening and opening. At present we are unable to measure these changes accurately. If we were able to do this, we may be able to predict when labour may start.

ECCLIPPx^TM I has recently demonstrated that a novel technology called Electrical Impedance Spectroscopy –EIS– which assesses electrical changes in the cervix (called “impedance” or “resistance”) may be useful to predict when premature labour will occur. The study showed that women who are higher risk of delivering prematurely have lower cervical “resistance” in mid-pregnancy than those who deliver at term.

In order to improve the accuracy of EIS and reduce potential sources of error, a new technique has been proposed which is known as Magnetic Impedance Spectroscopy (MIS). MIS contactlessly measures the cervical “resistance” by using safe magnetic fields and obtaining information about the tissue through which the current flows. We aim to investigate whether this new technique can predict premature birth better than EIS and whether pregnant women find the new device acceptable.

The current study will be recruiting two main groups of women: those at high risk of preterm birth and those presenting with symptoms of preterm birth.

High risk women:

•  Who is included in the high risk group? Any woman who has had a previous preterm delivery (before 37 weeks gestation) or a late miscarriage (after 14 weeks) is eligible to participate.

Symptomatic women:

•  Who is included in the symptomatic group? Women presenting to hospital with symptoms of threatened preterm labour (i.e. abdominal pain/contractions between 24 and 37 weeks gestation) but whose waters have not broken.

Microbiome study:

•  What is the microbiome study and who can take part? The microbiome study aims to perform detailed assessment of the vaginal flora (the many microorganisms which normally colonise the vagina) of women in the two study groups. Swabs will be taken as part of the study visits. There may be differences between the types of bacteria found in healthy pregnant woman who deliver prematurely and those whose pregnancies go to full term. We will find out if this is the case by analysing these swabs.

•  What does participating in the microbiome study involve? The swab-only study involves having an additional swab taken during a brief internal examination. Women with symptoms of preterm birth usually require an internal examination as part of their routine assessment. More information about the microbiome vaginal swab study is provided in the leaflet below.

For additional information, please contact us by email at Ecclippx@Sheffield.ac.uk

Future Studies:

If the current study confirms that spectroscopy is a useful test for predicting preterm birth, the next step will be to assess it as part of a randomised trial – such studies are designed to minimise bias in research results and provide the highest level of support for new tests and treatments.

PPI research group (patient participation and involvement):

ECCLIPPx^TM supports research which is not only aimed AT patients but also carried out BY patients in order to generate meaningful and sustainable changes in the NHS.

In 2012, a group of volunteers who had either experienced preterm birth first hand or who simply had an interest in trying to improve the health of mothers and babies in the region kindly began to give up some of their valuable spare time a few times a year to help with ECCLIPPx. The Jessop Wing Preterm Birth Patient and Public Involvement (PPI) group was finally founded, and that made all the difference. The essential contribution from the PPI group helped set ECCLIPPx into motion by bringing a new and fresh perspective into a team which until then had been mainly academic.

Over more than 5 years, the Preterm Birth PPI group at Jessop Wing has reviewed key applications, improved information patient leaflets and consent forms, and has helped maximise the impact of the project. Simultaneously, participants have been offered training in public engagement, and have had the chance to explore and discuss their views on how preterm birth could be reduced within a multidisciplinary team. The symbiosis has been so effective that one of the members of the PPI team was actually co-applicant in the project which has recently been awarded a major i4i NIHR grant!

ECCLIPPx clearly illustrates how patients and the public can play an essential role in the process of translating medical research from the bench to the bed.

If you are interested in participating in the conduct of this research by joining the PPI group please kindly make contact with Professor Dilly Anumba, Obstetric Consultant and Principal investigator (d.o.c.anumba@sheffield.ac.uk), Ms. Loretta Chantry-Groves, O, G & N Research Administrator (Loretta.Chantry-Groves@sth.nhs.uk) or Dr Brenda Narice, O&G Clinical Research Fellow (bnarice1@sheffield.ac.uk) with a very short personal statement.