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For researchers

This site contains trial documents and information for collaborators who recruit, collect data or in other ways are affiliated to the trial.

FAQ

What happens if the participant has more than one pregnancy in the trial period?

We only collect data on the first pregnancy after randomization that goes beyond 14+0 weeks of gestation.

What if the participant has a missed miscarriage/early miscarriage?

If the participant becomes pregnant again within the trial period, this information will be entered as past obstetric history.

Do I need certification to perform laparocopic cerclages in the NORACT trial?

Yes, you can read more about the certification process here.

I wish to offer a participant a pessary alongside her cerclage

Due to risk of cervical damage when a pessary is used simultaneously with a trasnvaginal cerclage, we ask that you do not offer NORACT participants a pessary.

Can the abdominal cerclage be performed via open access surgery?

No, the abdominal cerclage must be inserted using laparoscopic or robot-assisted surgery.

At which time points should we measure the cervical length using transvaginal ultrasound?

We ask that you measure the cervical length at

  • The screening visit
  • After insertion of the cerclage
  • In gestational age 18+0 – 21+6
  • In gestational age 22+0 – 25+6

Images of your measurements can be uploaded directly into REDCap or sent by e-mail to auh.noract@rm.dk

Do I need certification to perform the transvaginal ultrasound scans?

No, but we highly recommend it. Read here for more information on the certification proces.

Should all NORACT participants be treated with progesterone?

Yes, we recommend a prescription of 200 mg progesterone daily from week 16-34. Other doses can be accepted according to local guidelines.

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

NORACT trial registration on clinicaltrials.org