3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 11 sources, which was discussed by the committee. The evidence included 2 systematic reviews, 4 non-randomised comparative studies (2 of which were also included in 1 of the systematic reviews), 4 case series (1 of which was also included in 1 of the systematic reviews) and 1 case report (1 article reported both a case series and a systematic review), and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: live birth rate, gestational age at delivery and reduced pain compared with open surgery.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: pregnancy loss, bleeding, infection, unintentional damage to adjacent organs and gas embolus.
3.4 No patient commentary was sought.
3.5 Different materials are used for this procedure, including sutures and tapes.
3.6 For both laparoscopic and open transabdominal cerclage, there is uncertainty about the optimal timing of the procedure.
3.7 The committee was told that there is a potential risk of uterine rupture if labour starts when the suture or tape is in place.