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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Laparoscopic cerclage
Procedure/SurgeryClassic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.
Vaginal cerclage
Procedure/SurgeryTransvaginal cerclage in pregnant women.
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Delivery <32+0 weeks of gestation.
In the first subsequent viable pregnancy beyond 14+0 weeks of gestation. First prioritized primary outcome.
Time frame
At birth.2
Baby death.
Loss of a viable pregnancy beyond 14+0 weeks of gestation, miscarriage, stillbirth or death of a live born infant. Second prioritized primary outcome.
Time frame
From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.Secondary outcomes
1
Maternal mortality - surgery related.
Death.
Time frame
30 days after insertion of laparoscopic or vaginal cerclage.2
Maternal mortality.
Death.
Time frame
From time of randomisation - 42 days after delivery.3
Maternal morbidity - surgery related.
Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.
Time frame
30 days after insertion of laparoscopic or vaginal cerclage.4
Maternal morbidity
Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.
Time frame
From time of randomisation - 42 days after delivery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov