Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic cerclage, Vaginal cerclage.
- Who it may be relevant to
- Registry conditions: Preterm Birth, Cervical Insufficiency. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
Both vaginal and abdominal cerclages are procedures that have been used to prevent preterm birth for more than 50 years. However, only one previous study (MAVRIC, Shennan et al. 2020) has compared the two methods in a randomised trial. Other than evidence from the MAVRIC trial there is uncertainty whether an abdominal cerclage should be preferred over vaginal cerclage, and which women would benefit from it the most.
NORACT is an open, multicenter, superiority, randomized controlled trial with the overall objective to compare laparoscopic versus vaginal cerclage in woman in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth. Participants will be recruited pre-pregnancy or in early pregnancy and randomised to vaginal or laparoscopic cerclage. If randomised to laparoscopic cerclage this will be inserted pre-pregnancy or before 10+0 weeks of gestation. The vaginal cerclage will be inserted during pregnancy, before 16+0 weeks of gestation. A total sample of 188 participants will be included to detect a target difference of 15% in the primary outcome between the two groups. The two primary outcomes are delivery before 32+0 weeks of gestation and baby death. The study extends from sites in Denmark, Sweden, Norway, Finland, Iceland, and the United Kingdom.
Interventions
- Procedure Laparoscopic cerclage
Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women. - Procedure Vaginal cerclage
Transvaginal cerclage in pregnant women.
Primary outcome measures
- Delivery <32+0 weeks of gestation. [Time frame: At birth.]
- Baby death. [Time frame: From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.]
Secondary outcome measures (12)
- Maternal mortality - surgery related. [Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.]
- Maternal mortality. [Time frame: From time of randomisation - 42 days after delivery.]
- Maternal morbidity - surgery related. [Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.]
- Maternal morbidity [Time frame: From time of randomisation - 42 days after delivery.]
- Harm to participant - surgery related. [Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.]
- Harm to participant [Time frame: From time of cerclage procedure - 42 days after delivery.]
- Bleeding - surgery related. [Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.]
- Bleeding - pregnancy related. [Time frame: From time of cerclage procedure - 42 days after delivery.]
- Maternal infection - surgery related. [Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.]
- Maternal infection - pregnancy related. [Time frame: From time of cerclage procedure - 42 days after delivery]
- Maternal serious infection - pregnancy related. [Time frame: From time of cerclage procedure - 42 days after delivery.]
- Maternal serious infection - surgery related. [Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 2 centers
- Aarhus University Hospital — Aarhus N
- Rigshospitalet — Copenhagen
Publications
- Hansen LK, Krogh LQ, Lantto A, Uldbjerg N, Jensen PT, Shennan A, Hald K, Heikinheimo O, Jacobsson B, Hjartardottir H, Karypidis H, Glavind J. Nordic randomised trial on laparoscopic versus vaginal cerclage (NORACT): trial protocol for an international, multicentre, randomised controlled trial. BMJ Open. 2025 Sep 23;15(9):e107093. doi: 10.1136/bmjopen-2025-107093. PMID 40987744
Identifiers
NCT: NCT06122506 · 06190 · NNF21OC0071037