Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

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

Interventions

PROCEDURE

Laparoscopic cerclage

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

PROCEDURE

Vaginal cerclage

Transvaginal cerclage in pregnant women.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Viborg Regional Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Regionshospital Nordjylland

  collaborator OTHER_GOV

• Odense University Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Horsens Hospital

  collaborator OTHER

• Bornholm Hospital, Denmark

  collaborator UNKNOWN

• Lund University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Niels Uldbjerg, DMSc · Aarhus University Hospital

• Julie Glavind, MD, PhD · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-31

Primary Completion

2027-12-31

Completion

2028-03-31

Countries

• Denmark

Study Locations