RESCUE (version 1.0)
Research type
Research Study
Full title
Prediction of successful rescue cerclage: potential value of markers of inflammation and infection in amniotic fluid
IRAS ID
181999
Contact name
Ranjit Akolekar
Contact email
Sponsor organisation
Medway NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
The management of pregnant women who present with “silent dilatation” of the cervix (neck of the womb) in the mid-trimester remains a challenge. Without intervention, the vast majority of women will either miscarry or deliver prematurely. Insertion of a “rescue” cervical cerclage (stitch) can result in significant pregnancy prolongation and possible improvement in perinatal outcome. However, extreme prematurity still occurs in almost half of cases. There is some evidence that insertion of a cervical cerclage may increase the risk of maternal infection and sepsis.
Based on studies of women in premature labour or with premature rupture of membranes, where intra-amniotic rates of infection/inflammation are reported to be as high as 40%, several authors have hypothesised that failed rescue cerclage is the result of subclinical pre-existing intra-amniotic infection. However, in women presenting with silent dilatation of the cervix, there are no reliable methods with sufficient accuracy to identify such cases prior to the decision for insertion of a rescue cerclage. Several studies have investigated the use of amniocentesis in women with silent dilatation of the cervix and demonstrated an association between the presence of intra-amniotic infection and/or inflammation and poor outcome. However, these studies have a significant selection bias as they used the presence of such markers to decide whether the cerclage should be inserted.
In our hospital, women presenting with silent dilatation of the cervix in mid-trimester are routinely offered rescue cerclage. In this study we plan to analyse the amniotic fluid for markers of infection and inflammation to determine whether there is a correlation between sub-clinical infection/inflammation and failed cerclage.
REC name
London - Bromley Research Ethics Committee
REC reference
16/LO/1877
Date of REC Opinion
1 Mar 2017
REC opinion
Further Information Favourable Opinion