Preterm BirthNORACTNCT06122506
Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
A study testing Laparoscopic cerclage and Vaginal cerclage in people with Preterm Birth and Cervical Insufficiency, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Cervical Insufficiency
- What is being tested?
- Laparoscopic cerclage and Vaginal cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesDenmark
- Study dates
- 31 Jan 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N
LEA HANSEN, MD, 51910993, lea.hansen@clin.au.dk
LEA HANSEN, MD
- Recruiting
Rigshospitalet
Copenhagen
Lone Storgaard, PhD
About this study
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
Read the 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.
- Conditions
- Preterm Birth, Cervical Insufficiency
- Being tested
- Laparoscopic cerclage, Vaginal cerclage
- Keywords
- cerclage
- Medical subject headings
- Premature Birth, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cerclageProcedure or surgery
Also called Abdominal cerclage
Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.
Vaginal cerclageProcedure or surgery
Transvaginal cerclage in pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Laparoscopic cerclage Receives: Procedure: Laparoscopic cerclage |
| Control | Experimental | Vaginal cerclage Receives: Procedure: Vaginal cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery <32+0 weeks of gestation.
In the first subsequent viable pregnancy beyond 14+0 weeks of gestation. First prioritized primary outcome.
Measured: 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.
Measured: 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.
Death.
Measured: 30 days after insertion of laparoscopic or vaginal cerclage.
Maternal mortality.
Death.
Measured: From time of randomisation - 42 days after delivery.
Maternal morbidity - surgery related.
Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.
Measured: 30 days after insertion of laparoscopic or vaginal cerclage.
Maternal morbidity
Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.
Measured: From time of randomisation - 42 days after delivery.
Harm to participant - surgery related.
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.
Measured: 30 days after insertion of laparoscopic or vaginal cerclage.
Harm to participant
One or more of the following: Damage to internal organs, thromboembolic events (defined as deep vein thrombosis, pulmonary embolism or stroke), maternal cardiopulmonary arrest.
Measured: From time of cerclage procedure - 42 days after delivery.
Bleeding - surgery related.
Blood loss > 500 ml.
Measured: 30 days after insertion of laparoscopic or vaginal cerclage.
Bleeding - pregnancy related.
Blood loss > 1000 ml.
Measured: From time of cerclage procedure - 42 days after delivery.
Maternal infection - surgery related.
Leading to antibiotic treatment, but not ICU.
Measured: 30 days after insertion of laparoscopic or vaginal cerclage.
Maternal infection - pregnancy related.
Leading to antibiotic treatment, but not ICU
Measured: From time of cerclage procedure - 42 days after delivery
Maternal serious infection - pregnancy related.
Admission to ICU due to serious infection.
Measured: From time of cerclage procedure - 42 days after delivery.
Maternal serious infection - surgery related.
Admission to ICU due to serious infection.
Measured: 30 days after insertion of laparoscopic or vaginal cerclage.
PPROM.
Preterm prelabour rupture of membranes, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Threatened preterm labour.
Threatened preterm labour requiring admission and intervention, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Onset of labour.
Spontaneous labor contractions, PROM, induction of labor, c-section. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Mode of birth.
Unassisted vaginal, assisted vaginal (ventouse or forceps), caesarean section (planned, non-planned). In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Modified neonatal mortality.
Death of a liveborn child > 22+0 weeks of gestation.
Measured: From birth - four weeks after due date. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Neonatal mortality.
Death in the 1st 28 days of life > 22+0 weeks of gestation.
Measured: From birth - 28 days post delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Fetal loss.
Composite of late miscarriage and stillbirth, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At due date.
Late miscarriage.
Loss of viable pregnancy between gestational age 14+0-21+6, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At due date.
Gestational age at birth.
Gestational age at birth, weeks and days, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Delivery < 28 weeks.
Birth before gestational age 28+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Delivery < 34 weeks.
Birth before gestational age 34+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Delivery < 37 weeks.
Birth before gestational age 37+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Birthweight.
Grams. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: At birth.
Neonatal admission.
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)
Measured: From birth - four weeks after due date.
CNS morbidity.
Intraventricular Hemorrhage Grade III and IV and/or Periventricular leukomalacia. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: From birth - four weeks after due date.
Ocular morbidity.
Retinopathy requiring treatment. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: From birth - four weeks after due date.
Gastrointestinal morbidity.
Necrotizing Enterocolitis (NEC) and/or SIP (Spontaneous intestinal perforation), requiring surgery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: From birth - four weeks after due date.
Respiratory support.
Mechanical ventilation or non-invasive ventilation. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: From birth - four weeks after due date.
Respiratory distress syndrome (RDS).
Need for surfactant treatment. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Measured: First two days of life.
Early onset neonatal infection.
>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.
Measured: From birth - four weeks after due date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start31 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Viborg Regional Hospital, Gødstrup Hospital, Aalborg University Hospital, Randers Regional Hospital, Regionshospital Nordjylland, Odense University Hospital, Hvidovre University Hospital, Oslo University Hospital, Herlev Hospital, Aarhus University Hospital, Horsens Hospital, Bornholm Hospital, Denmark, Lund University Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Uldbjerg, DMSc, Study director, Aarhus University HospitalJulie Glavind, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122506
- Sponsor's protocol ID
- 06190
- Other IDs
- NNF21OC0071037
- Acronym
- NORACT
- Status last verified
- Sep 2024
- First submitted
- 3 Nov 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the trial results, the final dataset will be publicly available in an anonymized form using i.e. Zenodo open data repository (CERN) or another equivalent database.
Publications
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.
PubMed 40987744
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage
- ClinicalTrials.gov ID
- NCT06122506
- Acronym / sponsor ID
- NORACT / 06190
- Conditions
- Preterm Birth, Cervical Insufficiency
- Keywords
- cerclage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Viborg Regional Hospital, Gødstrup Hospital, Aalborg University Hospital, Randers Regional Hospital, Regionshospital Nordjylland, Odense University Hospital, Hvidovre University Hospital, Oslo University Hospital, Herlev Hospital, Aarhus University Hospital, Horsens Hospital, Bornholm Hospital, Denmark, Lund University Hospital
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Laparoscopic cerclageLaparoscopic cerclage |
| Control | Experimental | Procedure: Vaginal cerclageVaginal cerclage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cerclageAlso: Abdominal cerclageClassic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women. | Procedure or surgery | Intervention |
| Vaginal cerclageTransvaginal cerclage in pregnant women. | Procedure or surgery | Control |
Primary outcome
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.
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.
32 secondary outcomes
Maternal mortality - surgery related.
Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.
Maternal mortality.
Time frame: From time of randomisation - 42 days after delivery.
Maternal morbidity - surgery related.
Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.
Maternal morbidity
Time frame: From time of randomisation - 42 days after delivery.
Harm to participant - surgery related.
Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.
Harm to participant
Time frame: From time of cerclage procedure - 42 days after delivery.
Bleeding - surgery related.
Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.
Bleeding - pregnancy related.
Time frame: From time of cerclage procedure - 42 days after delivery.
Maternal infection - surgery related.
Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.
Maternal infection - pregnancy related.
Time frame: 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.
Maternal serious infection - surgery related.
Time frame: 30 days after insertion of laparoscopic or vaginal cerclage.
PPROM.
Time frame: At birth.
Threatened preterm labour.
Time frame: At birth.
Onset of labour.
Time frame: At birth.
Mode of birth.
Time frame: 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.
Neonatal mortality.
Time frame: From birth - 28 days post delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.
Fetal loss.
Time frame: At due date.
Late miscarriage.
Time frame: At due date.
Gestational age at birth.
Time frame: At birth.
Delivery < 28 weeks.
Time frame: At birth.
Delivery < 34 weeks.
Time frame: At birth.
Delivery < 37 weeks.
Time frame: At birth.
Birthweight.
Time frame: At birth.
Neonatal admission.
Time frame: From birth - four weeks after due date.
CNS morbidity.
Time frame: From birth - four weeks after due date.
Ocular morbidity.
Time frame: From birth - four weeks after due date.
Gastrointestinal morbidity.
Time frame: From birth - four weeks after due date.
Respiratory support.
Time frame: From birth - four weeks after due date.
Respiratory distress syndrome (RDS).
Time frame: First two days of life.
Early onset neonatal infection.
Time frame: From birth - four weeks after due date.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 40987744Hansen 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.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After publication of the trial results, the final dataset will be publicly available in an anonymized form using i.e. Zenodo open data repository (CERN) or another equivalent database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niels Uldbjerg, DMSc study director
Aarhus University Hospital
Julie Glavind, MD, PhD principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cerclage and Vaginal cerclage in people with Preterm Birth and Cervical Insufficiency, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lea K Hansen, MD (+45 51910993, lea.hansen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery <32+0 weeks of gestation. (time frame: At birth.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.