Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06122506
Study type	Interventional
Source	University of Aarhus
Contact	Lea K Hansen, MD
Phone	+45 51910993
Email	lea.hansen@clin.au.dk
Status	Recruiting
Phase	N/A
Start date	November 9, 2023
Completion date	March 2028

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Completed	`NCT05502510` - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Completed	`NCT02993744` - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone	N/A
Active, not recruiting	`NCT02673216` - Infection and Adverse Pregnancy Outcome
Completed	`NCT01683565` - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood	Phase 4
Completed	`NCT01412931` - Protein and Ultrasound Indicators of Preterm Birth	N/A
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT02606058` - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?	N/A
Terminated	`NCT03715530` - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women	N/A
Completed	`NCT00422526` - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial	Phase 3
Enrolling by invitation	`NCT04251260` - Effectiveness of Positioning in Preterm Neonates	N/A
Completed	`NCT03668860` - India Dexamethasone and Betamethasone	Phase 1
Recruiting	`NCT03638037` - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed	`NCT02225353` - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery	Phase 2
Recruiting	`NCT03992534` - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth	Phase 1
Completed	`NCT03144141` - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery	N/A
Completed	`NCT05210985` - Examination of the Relationship Between Home Affordances With Development
Completed	`NCT04811742` - Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage — NORACT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms