Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

NCT06122506 | Recruiting DMC

• 2 other identifiers: 06190NNF21OC0071037
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

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

Conditions

Preterm Birth; Cervical Insufficiency

Keywords

cerclage

Outcome Measures

Primary Outcomes (2)

• Delivery <32+0 weeks of gestation.

  In the first subsequent viable pregnancy beyond 14+0 weeks of gestation. First prioritized primary outcome.

  At birth.

• Baby death.

  Loss of a viable pregnancy beyond 14+0 weeks of gestation, miscarriage, stillbirth or death of a live born infant. Second prioritized primary outcome.

  From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Secondary Outcomes (32)

• Maternal mortality - surgery related.

  30 days after insertion of laparoscopic or vaginal cerclage.

• Maternal mortality.

  From time of randomisation - 42 days after delivery.

• Maternal morbidity - surgery related.

  30 days after insertion of laparoscopic or vaginal cerclage.

• Maternal morbidity

  From time of randomisation - 42 days after delivery.

• Harm to participant - surgery related.

  30 days after insertion of laparoscopic or vaginal cerclage.

Study Arms (2)

Intervention

EXPERIMENTAL

Laparoscopic cerclage

Procedure: Laparoscopic cerclage

Control

EXPERIMENTAL

Vaginal cerclage

Procedure: Vaginal cerclage

Interventions

Laparoscopic cerclage PROCEDURE

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

Also known as: Abdominal cerclage

Intervention

Vaginal cerclage PROCEDURE

Transvaginal cerclage in pregnant women.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility based on biologic sex.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Rigshospitalet, Denmark: collaborator
• Viborg Regional Hospital: collaborator
• Gødstrup Hospital: collaborator
• Aalborg University Hospital: collaborator
• Randers Regional Hospital: collaborator
• Regionshospital Nordjylland: collaborator
• Odense University Hospital: collaborator
• Hvidovre University Hospital: collaborator
• Oslo University Hospital: collaborator
• Herlev Hospital: collaborator
• Aarhus University Hospital: collaborator
• Horsens Hospital: collaborator
• Bornholm Hospital, Denmark: collaborator
• Lund University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus N, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Related Publications (1)

• 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 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Premature Birth; Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Genital Diseases

Study Officials

• Niels Uldbjerg, DMSc

  Aarhus University Hospital

  STUDY DIRECTOR

• Julie Glavind, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea K Hansen, MD

CONTACT

+45 51910993; lea.hansen@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: January 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning three months and ending three years after the publication of the last trial results.
• Access Criteria: Data will be available for any research purpose to all interested parties who have approval from an independent review committee. Interested parties will be able to request the data by contacting the trial sponsor. Authorship of publications emerging from the shared data will follow standard authorship guidelines and will include authors from the NORACT Board depending on the nature of their involvement.

Locations

DK (2)