Faculty of Health Sciences
School of Medicine
Department of Obstetrics and Gynaecology
The prevention of preterm delivery in women with cervical incompetence: A randomised controlled and obeservational trial with cerclage, with and without cervical occlusion
Preterm birth is the single most important cause of neonatal mortality, morbidity and later, neurological handicap. The birth of a preterm baby carries substantial cost in human and socio-economic terms.(1) A strong risk factor for preterm birth is a prior history of cervical incompetence, based on a history of repeated, painless, mid-trimester losses or preterm delivery. The incompetence may be demontrated on ultrasound as a shortening of the cervical length. Previous studies have indicated that intrauterine infection caused by ascending infection from the vagina, leads to preterm delivery as well as to spastic cerebral palsy. In recent years the importance of the cervical mucus plug a a gate-keeper protecting the feto-placental unit agianst ascending infection from the vagina, has been demonstrated. Preliminary studies have indicated that the combination of a cervical cerclage against incompetence, and occlusion of the external cervical os(to retain the mucus plug) protect against extreme preterm labour. The surgical treatment has previously been the vaginal placement of a cervical suture, despite limited evidence of a positive effect. The protocol is a large, simply designed, randomised-controlled, pragmatic multicentre trial, to confirm or refute the anticipated benefits of cervical occlusion, versus single cerclage, in cases indicated by a clinician, either because of previous history or because of shortening of the cervix on ultrasound. Additionally the collaboration will give the opportunity to give a more detailed characterisation of the group of women at repeated risk of preterm labour.
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