Cervical Electrical Impedance Measurement for Predicting Preterm Birth
Research type
Research Study
Full title
Assessing the Risk of Spontaneous Premature Birth by Electrical Impedance Spectroscopy of the Cervix -“(ECCLIPPx-EleCtriCaL Impedance Prediction of Preterm birth by spectroscopy of the cerviX)”.
IRAS ID
131508
Contact name
Dilly Anumba
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Research summary
The timing of birth is crucial to reproduction. 8-13% of babies are born prematurely at annual costs to the NHS of £1bn more than for term babies. A quarter of babies born at less than 28 gestational weeks suffer handicap, with socioeconomic burdens on society, parents often having to give up work to care for their child. Prevention of PTB is limited by the lack of accurate prediction of risk. Electrical impedance spectroscopy (EIS) is a technique which may enable prediction of PTB risk. In 40 women at risk of PTB (on the basis of a previous history) we recently showed that cervical impedance (CI) between 20 and 28 weeks gestation predicts PTB before 34 wks. Given the small numbers in the pilot we seek to undertake larger studies on larger cohorts to definitively determine predictive utility of CI for PTB.
We aim to:
a) improve the accuracy of the EIS measuring device and then determine the accuracy of CI-based prediction of spontaneous PTB in 250 high-risk women studied at 20-22 and 26-28 wks, and 250 women with no risk factors, comparing CI to cervix length and the fibronectin test used in some clinical settings, and assessing whether determining vaginal microbiota using global array technology would prove a screening tool for PTB secondary to CI;
b) assess cost-effectiveness & acceptability of CI assessment, and design a study incorporating CI into current PTB screening pathways (Phase 3).
c) Study 100 women presenting with symptoms of threatened preterm labour to determine the accuracy of CI-based prediction of preterm labour and spontaneous PTB.
Test the above hypotheses that CI assessment has a place in the screening and care for preterm birth by designing an intervention randomised trial to clarify its value during pregnancy care.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0167
Date of REC Opinion
26 Jun 2013
REC opinion
Further Information Favourable Opinion