Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Aarhus

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Laparoscopic cerclage
  • Vaginal cerclage

Treatment groups

188 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Aarhus

Lead sponsor

Rigshospitalet, Denmark

Collaborator

Viborg Regional Hospital

Collaborator

Gødstrup Hospital

Collaborator

Aalborg University Hospital

Collaborator

Randers Regional Hospital

Collaborator

Regionshospital Nordjylland

Collaborator

Odense University Hospital

Collaborator

Hvidovre University Hospital

Collaborator

Oslo University Hospital

Collaborator

Herlev Hospital

Collaborator

Aarhus University Hospital

Collaborator

Horsens Hospital

Collaborator

Bornholm Hospital, Denmark

Collaborator

Lund University Hospital

Collaborator