Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Birth
- Sponsor
- University of Aarhus
- Enrollment
- 188
- Locations
- 2
- Primary Endpoint
- Delivery <32+0 weeks of gestation.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Delivery <32+0 weeks of gestation.
Time Frame: At birth.
In the first subsequent viable pregnancy beyond 14+0 weeks of gestation. First prioritized primary outcome.
Baby death.
Time Frame: From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Loss of a viable pregnancy beyond 14+0 weeks of gestation, miscarriage, stillbirth or death of a live born infant. Second prioritized primary outcome.
Secondary Outcomes
- Threatened preterm labour.(At birth.)
- Onset of labour.(At birth.)
- CNS morbidity.(From birth - four weeks after due date.)
- Maternal mortality.(From time of randomisation - 42 days after delivery.)
- Maternal mortality - surgery related.(30 days after insertion of laparoscopic or vaginal cerclage.)
- Harm to participant - surgery related.(30 days after insertion of laparoscopic or vaginal cerclage.)
- Harm to participant(From time of cerclage procedure - 42 days after delivery.)
- Maternal infection - surgery related.(30 days after insertion of laparoscopic or vaginal cerclage.)
- Late miscarriage.(At due date.)
- Delivery < 34 weeks.(At birth.)
- Delivery < 37 weeks.(At birth.)
- Ocular morbidity.(From birth - four weeks after due date.)
- Neonatal admission.(From birth - four weeks after due date.)
- Maternal morbidity(From time of randomisation - 42 days after delivery.)
- Bleeding - surgery related.(30 days after insertion of laparoscopic or vaginal cerclage.)
- Bleeding - pregnancy related.(From time of cerclage procedure - 42 days after delivery.)
- PPROM.(At birth.)
- Neonatal mortality.(From birth - 28 days post delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.)
- Maternal morbidity - surgery related.(30 days after insertion of laparoscopic or vaginal cerclage.)
- Maternal infection - pregnancy related.(From time of cerclage procedure - 42 days after delivery)
- Maternal serious infection - pregnancy related.(From time of cerclage procedure - 42 days after delivery.)
- Maternal serious infection - surgery related.(30 days after insertion of laparoscopic or vaginal cerclage.)
- Mode of birth.(At birth.)
- Modified neonatal mortality.(From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.)
- Gestational age at birth.(At birth.)
- Birthweight.(At birth.)
- Gastrointestinal morbidity.(From birth - four weeks after due date.)
- Early onset neonatal infection.(From birth - four weeks after due date.)
- Fetal loss.(At due date.)
- Delivery < 28 weeks.(At birth.)
- Respiratory support.(From birth - four weeks after due date.)
- Respiratory distress syndrome (RDS).(First two days of life.)