- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06122506
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage (NORACT)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lea K Hansen, MD
- Phone Number: +45 51910993
- Email: lea.hansen@clin.au.dk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Laparoscopic cerclage
|
Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.
Other Names:
|
Experimental: Control
Vaginal cerclage
|
Transvaginal cerclage in pregnant women.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delivery <32+0 weeks of gestation.
Time Frame: At birth.
|
In the first subsequent viable pregnancy beyond 14+0 weeks of gestation.
First prioritized primary outcome.
|
At birth.
|
Baby death.
Time Frame: From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal mortality - surgery related.
Time Frame: 30 days after insertion of laparoscopic or vaginal cerclage.
|
Death.
|
30 days after insertion of laparoscopic or vaginal cerclage.
|
Maternal mortality.
Time Frame: From time of randomisation - 42 days after delivery.
|
Death.
|
From time of randomisation - 42 days after delivery.
|
Maternal morbidity - surgery related.
Time Frame: 30 days after insertion of laparoscopic or vaginal cerclage.
|
Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.
|
30 days after insertion of laparoscopic or vaginal cerclage.
|
Maternal morbidity
Time Frame: From time of randomisation - 42 days after delivery.
|
Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.
|
From time of randomisation - 42 days after delivery.
|
Harm to participant - surgery related.
Time Frame: 30 days after insertion of laparoscopic or vaginal cerclage.
|
One or more of the following: Damage to internal organs, need for re-operation, thromboembolic events (defined as deep vein thrombosis, pulmonary embolism or stroke), maternal cardiopulmonary arrest.
|
30 days after insertion of laparoscopic or vaginal cerclage.
|
Harm to participant
Time Frame: From time of cerclage procedure - 42 days after delivery.
|
One or more of the following: Damage to internal organs, thromboembolic events (defined as deep vein thrombosis, pulmonary embolism or stroke), maternal cardiopulmonary arrest.
|
From time of cerclage procedure - 42 days after delivery.
|
Bleeding - surgery related.
Time Frame: 30 days after insertion of laparoscopic or vaginal cerclage.
|
Blood loss > 500 ml.
|
30 days after insertion of laparoscopic or vaginal cerclage.
|
Bleeding - pregnancy related.
Time Frame: From time of cerclage procedure - 42 days after delivery.
|
Blood loss > 1000 ml.
|
From time of cerclage procedure - 42 days after delivery.
|
Maternal infection - surgery related.
Time Frame: 30 days after insertion of laparoscopic or vaginal cerclage.
|
Leading to antibiotic treatment, but not ICU.
|
30 days after insertion of laparoscopic or vaginal cerclage.
|
Maternal infection - pregnancy related.
Time Frame: From time of cerclage procedure - 42 days after delivery
|
Leading to antibiotic treatment, but not ICU
|
From time of cerclage procedure - 42 days after delivery
|
Maternal serious infection - pregnancy related.
Time Frame: From time of cerclage procedure - 42 days after delivery.
|
Admission to ICU due to serious infection.
|
From time of cerclage procedure - 42 days after delivery.
|
Maternal serious infection - surgery related.
Time Frame: 30 days after insertion of laparoscopic or vaginal cerclage.
|
Admission to ICU due to serious infection.
|
30 days after insertion of laparoscopic or vaginal cerclage.
|
PPROM.
Time Frame: At birth.
|
Preterm prelabour rupture of membranes, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Threatened preterm labour.
Time Frame: At birth.
|
Threatened preterm labour requiring admission and intervention, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Onset of labour.
Time Frame: At birth.
|
Spontaneous labor contractions, PROM, induction of labor, c-section.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Mode of birth.
Time Frame: At birth.
|
Unassisted vaginal, assisted vaginal (ventouse or forceps), caesarean section (planned, non-planned).
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Modified neonatal mortality.
Time Frame: From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
Death of a liveborn child > 22+0 weeks of gestation.
|
From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
Neonatal mortality.
Time Frame: From birth - 28 days post delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
Death in the 1st 28 days of life > 22+0 weeks of gestation.
|
From birth - 28 days post delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
Fetal loss.
Time Frame: At due date.
|
Composite of late miscarriage and stillbirth, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At due date.
|
Late miscarriage.
Time Frame: At due date.
|
Loss of viable pregnancy between gestational age 14+0-21+6, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At due date.
|
Gestational age at birth.
Time Frame: At birth.
|
Gestational age at birth, weeks and days, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Delivery < 28 weeks.
Time Frame: At birth.
|
Birth before gestational age 28+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Delivery < 34 weeks.
Time Frame: At birth.
|
Birth before gestational age 34+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Delivery < 37 weeks.
Time Frame: At birth.
|
Birth before gestational age 37+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Birthweight.
Time Frame: At birth.
|
Grams.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
At birth.
|
Neonatal admission.
Time Frame: From birth - four weeks after due date.
|
Number of consecutive days in hospital within 28 days from time of delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation. Any admission counts (SCBU, maternity ward, NICU) |
From birth - four weeks after due date.
|
CNS morbidity.
Time Frame: From birth - four weeks after due date.
|
Intraventricular Hemorrhage Grade III and IV and/or Periventricular leukomalacia.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
From birth - four weeks after due date.
|
Ocular morbidity.
Time Frame: From birth - four weeks after due date.
|
Retinopathy requiring treatment.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
From birth - four weeks after due date.
|
Gastrointestinal morbidity.
Time Frame: From birth - four weeks after due date.
|
Necrotizing Enterocolitis (NEC) and/or SIP (Spontaneous intestinal perforation), requiring surgery.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
From birth - four weeks after due date.
|
Respiratory support.
Time Frame: From birth - four weeks after due date.
|
Mechanical ventilation or non-invasive ventilation.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
From birth - four weeks after due date.
|
Respiratory distress syndrome (RDS).
Time Frame: First two days of life.
|
Need for surfactant treatment.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
First two days of life.
|
Early onset neonatal infection.
Time Frame: From birth - four weeks after due date.
|
>5 days of i.v.
antibiotics, where the treatment commences within the first week of life.
In the first subsequent viable pregnancy beyond 14 weeks of gestation.
|
From birth - four weeks after due date.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Niels Uldbjerg, DMSc, Aarhus University Hospital
- Principal Investigator: Julie Glavind, MD, PhD, Aarhus University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Uterine Cervical Diseases
- Uterine Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Abortion, Habitual
- Abortion, Spontaneous
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Premature Birth
- Uterine Cervical Incompetence
Other Study ID Numbers
- 06190
- NNF21OC0071037 (Other Grant/Funding Number: Novo Nordic Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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