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Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

RecruitingNAAges 18 Years - anyFemaleUniversity of Aarhus
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In plain words

What the trial is, and whether it could suit you

Every year 15 million babies are born prematurely, which can lead to death or life-long disabilities. It is often caused by a dysfunction of the uterine cervix, which constitutes the narrow channel between the vagina and womb. During pregnancy, this channel must remain closed until the beginning of term labor. A weak cervix may not withstand the weight of the fetus, the amniotic fluid and the placenta and the cervical canal will open and cause late miscarriage or preterm delivery. To prevent this, a band (cerclage) can be applied around the cervix either vaginally or laparoscopically prior to a new pregnancy. To evaluate which treatment is best for most women, we will randomize (allocate by chance) women at risk for preterm birth, to either vaginal cerclage or laparoscopic cerclage in the Nordic countries and England

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth. * Not yet pregnant or \<10 weeks' pregnant. Exclusion Criteria: * Any circumstance under which the clinician is not willing to randomize is an exclusion criterion. * Any condition or circumstance under which laparoscopic or vaginal cerclage surgery is contraindicated (i.e. on-going pregnancy of more than 10+0 gestational weeks). * Language difficulties.
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What it tests

  • Laparoscopic cerclage
  • Vaginal cerclage
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Where

2 sites
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet
Copenhagen, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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