Participation & Benefits
What is ECCLIPPxTM?
ECCLIPPxTM - EleCtriCaL Impedance Prediction of Preterm birth by spectroscopy of the cerviX
The ECCLIPPxTM project is a new research study, based in Sheffield, investigating the prediction of preterm birth. 8% of all births in the UK occur early, before 37 weeks’ gestation. We aim to assess whether a new test (impedance spectroscopy) can reliably identify women at high risk of premature delivery, so that we can offer them treatment to prolong pregnancy. (UKCRN ID - 15057)
The Current Study:
Overview: 8% of births in the UK occur early, before 37 weeks gestation period. 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. The purpose of this study is to assess whether a new device that measures electrical changes in the cervix (called “impedance” or “spectroscopy”) may be useful to predict when premature labour might start so that we can offer women treatment to prolong pregnancy if they are found to be at high risk. We aim to investigate whether this technique can be used routinely in antenatal care to predict premature birth.
The current study is recruiting three main groups of women: those at high risk of preterm birth, those at low risk of preterm birth and finally women 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.
Low risk women:
Who is included in the low risk group? Any woman who has not had a preterm birth is eligible to participate.
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.
What is the microbiome study and who can take part? The microbiome study aims to perform detailed assessment of the vaginal flora (the many bugs which normally colonise the vagina) of women in the three 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.
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):
The National Institute for Health Research defines public involvement in research as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. All teams conducting research within the NHS are encouraged to consult people who may be affected by the results of their research at an early stage - this ensures valuable insights, perspectives and skills are not overlooked.
The Jessop Wing has a longstanding history of involving women in the design and conduct of its research studies. The ECCLIPPxTM studies have the full participation of the Jessop Wing Preterm Birth PPI group. The group meets regularly, and is consulted fdor advice and input regarding all planned and ongoing studies in this area, to ensure a woman-centred focus is maintained, and that any technologies for pregnancy care which are generated from the studies are acceptable to prospective mothers and meet their needs and expectations.
If you are interested in participating in the conduct of this research by joining the PPI group please contact us by e-mail at Ecclippx@Sheffield.ac.uk.