Clinical trial NCT06122506: Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Official title: Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Cervical Insufficiency
Keywords: cerclage
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Viborg Regional Hospital
name: Gødstrup Hospital
name: Aalborg University Hospital
name: Randers Regional Hospital
name: Regionshospital Nordjylland
name: Odense University Hospital
name: Hvidovre University Hospital
name: Oslo University Hospital
name: Herlev Hospital
name: Aarhus University Hospital
name: Horsens Hospital
name: Bornholm Hospital, Denmark
name: Lund University Hospital
First posted: 2023-11-08
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Delivery <32+0 weeks of gestation.
timeFrame: At birth.
measure: Baby death.
timeFrame: From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Secondary outcomes:
measure: Maternal mortality - surgery related.
timeFrame: 30 days after insertion of laparoscopic or vaginal cerclage.
measure: Maternal mortality.
timeFrame: From time of randomisation - 42 days after delivery.
measure: Maternal morbidity - surgery related.
timeFrame: 30 days after insertion of laparoscopic or vaginal cerclage.
measure: Maternal morbidity
timeFrame: From time of randomisation - 42 days after delivery.
measure: Harm to participant - surgery related.
timeFrame: 30 days after insertion of laparoscopic or vaginal cerclage.
measure: Harm to participant
timeFrame: From time of cerclage procedure - 42 days after delivery.
measure: Bleeding - surgery related.
timeFrame: 30 days after insertion of laparoscopic or vaginal cerclage.
measure: Bleeding - pregnancy related.
timeFrame: From time of cerclage procedure - 42 days after delivery.
measure: Maternal infection - surgery related.
timeFrame: 30 days after insertion of laparoscopic or vaginal cerclage.
measure: Maternal infection - pregnancy related.
timeFrame: From time of cerclage procedure - 42 days after delivery
measure: Maternal serious infection - pregnancy related.
timeFrame: From time of cerclage procedure - 42 days after delivery.
measure: Maternal serious infection - surgery related.
timeFrame: 30 days after insertion of laparoscopic or vaginal cerclage.
measure: PPROM.
timeFrame: At birth.
measure: Threatened preterm labour.
timeFrame: At birth.
measure: Onset of labour.
timeFrame: At birth.
measure: Mode of birth.
timeFrame: At birth.
measure: Modified neonatal mortality.
timeFrame: From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
measure: Neonatal mortality.
timeFrame: From birth - 28 days post delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
measure: Fetal loss.
timeFrame: At due date.
measure: Late miscarriage.
timeFrame: At due date.
measure: Gestational age at birth.
timeFrame: At birth.
measure: Delivery < 28 weeks.
timeFrame: At birth.
measure: Delivery < 34 weeks.
timeFrame: At birth.
measure: Delivery < 37 weeks.
timeFrame: At birth.
measure: Birthweight.
timeFrame: At birth.
measure: Neonatal admission.
timeFrame: From birth - four weeks after due date.
measure: CNS morbidity.
timeFrame: From birth - four weeks after due date.
measure: Ocular morbidity.
timeFrame: From birth - four weeks after due date.
measure: Gastrointestinal morbidity.
timeFrame: From birth - four weeks after due date.
measure: Respiratory support.
timeFrame: From birth - four weeks after due date.
measure: Respiratory distress syndrome (RDS).
timeFrame: First two days of life.
measure: Early onset neonatal infection.
timeFrame: From birth - four weeks after due date.
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: København
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Aarhus University Hospital
name: Niels Uldbjerg, DMSc
role: STUDY_DIRECTOR
affiliation: Aarhus University Hospital
name: Julie Glavind, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: