CEAL Study
Research type
Research Study
Full title
A feasibility study to compare the relationship between uterine cervical length and elastance to determine the likelihood of spontaneous pre-term labour
IRAS ID
188330
Contact name
Mark Kilby
Contact email
Sponsor organisation
Birmingham Women's NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
Premature delivery is associated with increased perinatal death and significant morbidity. Premature birth occurs in around 50% of twin pregnancy with 10% before 32 weeks (NICE Guidelines 2011). The risk for preterm delivery is considerably higher in twin pregnancy when compared to singleton pregnancy.
There is research in the singleton population to suggest that the assessment of compliance or 'stiffness' of the uterine cervix using trans-vaginal ultrasound to measure cervical elastography may be a useful tool to predict risk of preterm birth.
NICE Guidance (2011) highlights the need for further research into the prediction of possible prevention of premature birth in multiple pregnancies.
This research will assess the relationship between the cervical length and elastograpghy in twin pregnancy. There is currently very little evidence/research into this topic. These data may potentially provide an insight into the clinical relevance of observed changes in cervical and composition and offer information important to the pathogenesis of pre-term birth. We will also look at a cohort of women with singleton pregnancy with poor obstetric history who are at an increased risk of pre-term birth to compare the outcome of cervical assessment with the twin population.
This is a pilot study of 30 women with a confirmed, uncomplicated twin pregnancy (both dichorionic and monochorionic twins) and 10 with a singleton pregnancy at 18 to 20+6 weeks gestation.
Measurement of cervical length and elastography using trans vaginal ultrasound will be undertaken to compare and contrast cervical length with the coressponding stiffness.
Audit of hospital notes at delivery will be completed to ascertain outcome details including gestational age at delivery and neonatal outcome of twins with regard to mortality & morbidity.
It is hoped that the outcome data will add to existing evidence in the area and provide data relating to the predictive value of measuring cervical length and compliance in pre term birth.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0079
Date of REC Opinion
29 Feb 2016
REC opinion
Further Information Favourable Opinion