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Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

NCT ID: NCT06122506

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2028-03-31

Brief Summary

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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

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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.

Conditions

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Preterm Birth Cervical Insufficiency

Keywords

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cerclage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Laparoscopic cerclage

Group Type EXPERIMENTAL

Laparoscopic cerclage

Intervention Type PROCEDURE

Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.

Control

Vaginal cerclage

Group Type EXPERIMENTAL

Vaginal cerclage

Intervention Type PROCEDURE

Transvaginal cerclage in pregnant women.

Interventions

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Laparoscopic cerclage

Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.

Intervention Type PROCEDURE

Vaginal cerclage

Transvaginal cerclage in pregnant women.

Intervention Type PROCEDURE

Other Intervention Names

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Abdominal cerclage

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Viborg Regional Hospital

OTHER

Sponsor Role collaborator

Gødstrup Hospital

OTHER

Sponsor Role collaborator

Aalborg University Hospital

OTHER

Sponsor Role collaborator

Randers Regional Hospital

OTHER

Sponsor Role collaborator

Regionshospital Nordjylland

OTHER_GOV

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Horsens Hospital

OTHER

Sponsor Role collaborator

Bornholm Hospital, Denmark

UNKNOWN

Sponsor Role collaborator

Lund University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels Uldbjerg, DMSc

Role: STUDY_DIRECTOR

Aarhus University Hospital

Julie Glavind, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus N, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lea K Hansen, MD

Role: CONTACT

Phone: +45 51910993

Email: [email protected]

Facility Contacts

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LEA HANSEN, MD

Role: primary

Lone Storgaard, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40987744 (View on PubMed)

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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http://www.noract.dk

Trial website

Other Identifiers

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NNF21OC0071037

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

06190

Identifier Type: -

Identifier Source: org_study_id