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NORACT

Trial Overview

NORACT is an open, multicenter, randomized controlled study with an embedded internal pilot trial. 

On this site you will find information on the organization of the pilot trial and the full trial.

  • P 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.
  • I   Laparoscopic cerclage pre-pregnancy or in early pregnancy
  • C  Vaginal cerclage in early pregnancy
  • O Delivery before 32 weeks of gestation

0

of 190 participants

Pilot study

Designed to evaluate the number of eligible participants and the feasibility and acceptability of the intervention.

0

of 18 Months

Timeline

1

Pilot study recruits

Summer 2023
2

Recruitment continues during evaluation of pilot study

Winter 2024
3

Evaluation of results from pilot study

Winter 2024

Population

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.

Examples of women who could participate in the study

Example 1

History of emergency/laboring cesarean section followed by a spontaneous singleton late miscarriage or PTB from 14+0 to 28+0* weeks

Example 2

History with a prior elective vaginal cerclage placement but nonetheless a spontaneous late miscarriage or PTB between 14+0 and 28+0* weeks

Example 3

History of a prior emergency cerclage with delivery between 14+0 and 28+0* weeks 

Example 4

Any conization and a short pre-pregnancy cervix (e.g. short ectocervix with inspection or below 15-20 mm with ultrasound)

Example 5

History of one or more deliveries GA 16+0 to 28+0 weeks and a clinical diagnosis of cervical insufficiency

Example 6

History of three or more deliveries GA 16+0 to 36+6 weeks

* Women with delivery up to 32 weeks might be considered depending on a clinical judgement

Contact information

Lea Kirstine Hansen
MD., Ph.D-student
Dept. of obstetrics and gynecology
Aarhus University Hospital

auh.noract@rm.dk

+45 51 72 45 64

Address

Dept. of obstetrics and gynecology
Aarhus University Hospital

Palle Juul-Jensens Boulevard 99
8200 Aarhus N