Preterm BirthTWIN CerclageNCT05968794
Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
A study testing Vaginal cerclage in people with Preterm Birth, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 13 sites in 2 countries.
Trial summary
The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Vaginal cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 15 May 2023to 1 Dec 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Women with a mono-amniotic twin pregnancy
- Women with twin pregnancy in which one or both children are diagnosed with a major structural, congenital or chromosomal abnormality that is likely to influence the composite adverse neonatal outcome.
- Women with dilatation of the cervix and signs of clinical intra-uterine infection, defined by the presence of fever ≥ 38 degrees Celsius.
- Women with overt symptoms of preterm labour at time of measurement of short cervix (regular contractions, PPROM, recurrent blood loss).
- Women with a placenta previa, defined as a placenta position covering the internal ostium of the cervix.
- Women who do not master the Dutch of English language and therefore not able to give written consent
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Martijn A Oudijk, MD, PhD, Prof contact
13 sites in 2 countries
Netherlands8 sites, 8 recruiting
- Recruiting
University Medical Center Amsterdam
Amsterdam
M.A. Oudijk, Prof.Dr.
- Not yet recruiting
University Medical Center Groningen
Groningen
J.R. Prins, Dr
- Not yet recruiting
University Medical Center Leiden
Leiden
E.M. Lutke-Holzik, Dr
- Not yet recruiting
University Medical Center Maastricht
Maastricht
S Al-Nassiry, Dr
- Not yet recruiting
Radboud University Medical Center
Nijmegen
J van Drongelen, Dr
- Not yet recruiting
Erasmus Medical Centre
Rotterdam
S Schoenmakers, Dr
- Not yet recruiting
University Medical Center Utrecht
Utrecht
J.B Derks, Dr
- Not yet recruiting
Maxima Medical Centre
Veldhoven
J van Laar, Dr
Belgium5 sites, 5 recruiting
- Not yet recruiting
University Medical Center Antwerpen
Antwerp
Y Jacquemyn, Prof. Dr.
- Not yet recruiting
University Medical Center Sint-Lucas Brugge
Bruges
C van Holsbeke, dr
- Not yet recruiting
Hospital Oost-Limburg Genk
Genk
W Gyselaers, Prof.Dr.
- Not yet recruiting
University Medical Center Gent
Ghent
I Dehaene, Dr.
- Not yet recruiting
University Medical Center Leuven
Leuven
L Lewi, Dr
About this study
Official title: The Effectiveness of Cerclage for the Reduction of Extreme Preterm Birth and Perinatal Mortality in Twin Pregnancies With a Short Cervix or Dilatation
The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age.
The main question it aims to answer is: What is the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age?
Participants will be randomly assigned to the intervention (cerclage) or comparison (no cerclage) group.
Read the detailed description
Rationale: In the Netherlands, 250 women with a twin pregnancy deliver at < 28 weeks per year, resulting in 157 perinatal deaths. A vaginal cerclage could be an effective surgical method to reduce cervical insufficiency and with that preterm birth, but the evidence regarding its effectiveness on extreme preterm birth and (long term) neonatal outcome is lacking.
Objective: To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A vaginal cerclage is a minor and safe surgical procedure commonly performed in singleton pregnancies with a short cervix and a previous preterm birth in all the participating centers, thus there is experience in the participating hospitals. The results of this study will show whether a vaginal cerclage reduces extreme preterm birth in women with twin pregnancy and a short cervix, and its accompanying perinatal complications. If proven effective, the implementation of this intervention will have a huge impact on the lifelong health of these children and their families.
- Conditions
- Preterm Birth
- Being tested
- Vaginal cerclage
- Keywords
- Preterm birth, Twin pregnancy, Cerclage
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal cerclageProcedure or surgery
A vaginal cerclage is a short and minor surgical procedure performed under general or regional anesthesia. An unabsorbable suture is placed around/through the cervix to close the cervical canal and to increase its firmness, in order to reduce cervical insufficiency.
| Study group | Role | What they receive |
|---|---|---|
| Cerclage | Experimental | A vaginal cerclage is a short and minor surgical procedure performed under general or regional anesthesia. An unabsorbable suture is placed around/through the cervix to close the cervical canal and to increase its firmness, in order to reduce cervical insufficiency. Receives: Procedure: Vaginal cerclage |
| Standard care | No intervention | The comparator will be standard treatment according to the current Dutch (NVOG) guideline from 2018, which is to not perform or offer an intervention such as vaginal cerclage. This is in line with the standard care in the participating hospitals in Belgium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of extreme preterm birth
Measured: <28 weeks of gestation
Secondary outcomes (15)
Rate of Preterm birth
Indicated and spontaneous
Measured: <24, <32, <34 and <37 weeks
Rate of Premature rupture of membranes
Measured: Up to 42 weeks of pregnancy
Gestational age at delivery
Measured: At delivery
Days on ventilation support
Neonatal
Measured: Up to 3 months corrected age
Days in NICU
Neonatal
Measured: Up to 3 months corrected age
Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score
The 'European Quality of life 5-Dimension 5-Level' score consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) that are rated using five levels (no problems (1), slight problems (2), moderate problems (3), severe problems (4), extreme problems (5)). A unique health state is defined by combining one level from each of the five dimensions. Each state is referred to by a 5-digit code, The best score is 11111 and the worst score is 55555.
Measured: Up to 3 months corrected age
Rate of maternal outcomes
Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery).
Measured: Up to 3 months corrected age
Adverse neonatal outcome
A composite for adverse neonatal outcome (including bronchopulmonary dysplasia, periventricular leucomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis > stage 2, retinopathy of prematurity > stage 2, proven sepsis and perinatal death)
Measured: Up to 3 months corrected age
Number of neonates with bronchopulmonary dysplasia
Measured: Up to 3 months corrected age
Number of neonates with periventricular leucomalacia > grade 1
Measured: Up to 3 months corrected age
Number of neonates with intraventricular hemorrhage > grade 2
Measured: Up to 3 months corrected age
Number of neonates with necrotizing enterocolitis > stage 2
Measured: Up to 3 months corrected age
Number of neonates with retinopathy of prematurity > stage 2
Measured: Up to 3 months corrected age
Number of neonates with proven sepsis
Measured: Up to 3 months corrected age
Perinatal death
Measured: Up to 3 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start15 May 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Dec 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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multicenter randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Martijn A. Oudijk, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968794
- Sponsor's protocol ID
- TwinC
- Acronym
- TWIN Cerclage
- Status last verified
- Nov 2023
- First submitted
- 22 Apr 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The manuscript will be published in an Open Access journal that provides a PID (e.g., a DOI or URN)
Publications
van Gils L, de Boer MA, Bosmans J, Duijnhoven R, Schoenmakers S, Derks JB, Prins JR, Al-Nasiry S, Lutke Holzik M, Lopriore E, van Drongelen J, Knol MH, van Laar JOEH, Jacquemyn Y, van Holsbeke C, Dehaene I, Lewi L, van der Merwe H, Gyselaers W, Obermann-Borst SA, Holthuis M, Mol BW, Pajkrt E, Oudijk MA. Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies. BMJ Open. 2024 May 10;14(5):e081561. doi: 10.1136/bmjopen-2023-081561.
PubMed 38729756
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cerclage for the Reduction of Extreme Preterm Birth and Perinatal Mortality in Twin Pregnancies With a Short Cervix or Dilatation
- ClinicalTrials.gov ID
- NCT05968794
- Acronym / sponsor ID
- TWIN Cerclage / TwinC
- Conditions
- Preterm Birth
- Keywords
- Preterm birth, Twin pregnancy, Cerclage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 15 May 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 1 Aug 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.
The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age.
The main question it aims to answer is: What is the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age?
Participants will be randomly assigned to the intervention (cerclage) or comparison (no cerclage) group.
Detailed description
Rationale: In the Netherlands, 250 women with a twin pregnancy deliver at < 28 weeks per year, resulting in 157 perinatal deaths. A vaginal cerclage could be an effective surgical method to reduce cervical insufficiency and with that preterm birth, but the evidence regarding its effectiveness on extreme preterm birth and (long term) neonatal outcome is lacking.
Objective: To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A vaginal cerclage is a minor and safe surgical procedure commonly performed in singleton pregnancies with a short cervix and a previous preterm birth in all the participating centers, thus there is experience in the participating hospitals. The results of this study will show whether a vaginal cerclage reduces extreme preterm birth in women with twin pregnancy and a short cervix, and its accompanying perinatal complications. If proven effective, the implementation of this intervention will have a huge impact on the lifelong health of these children and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- International, multicenter randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Cerclage | Experimental | Procedure: Vaginal cerclageA vaginal cerclage is a short and minor surgical procedure performed under general or regional anesthesia. An unabsorbable suture is placed around/through the cervix to close the cervical canal and to increase its firmness, in order to reduce cervical insufficiency. |
| Standard care | No intervention | –The comparator will be standard treatment according to the current Dutch (NVOG) guideline from 2018, which is to not perform or offer an intervention such as vaginal cerclage. This is in line with the standard care in the participating hospitals in Belgium. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Women with a mono-amniotic twin pregnancy
- Women with twin pregnancy in which one or both children are diagnosed with a major structural, congenital or chromosomal abnormality that is likely to influence the composite adverse neonatal outcome.
- Women with dilatation of the cervix and signs of clinical intra-uterine infection, defined by the presence of fever ≥ 38 degrees Celsius.
- Women with overt symptoms of preterm labour at time of measurement of short cervix (regular contractions, PPROM, recurrent blood loss).
- Women with a placenta previa, defined as a placenta position covering the internal ostium of the cervix.
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 |
|---|---|---|
| Vaginal cerclageA vaginal cerclage is a short and minor surgical procedure performed under general or regional anesthesia. An unabsorbable suture is placed around/through the cervix to close the cervical canal and to increase its firmness, in order to reduce cervical insufficiency. | Procedure or surgery | Cerclage |
Primary outcome
Rate of extreme preterm birth
Time frame: <28 weeks of gestation
15 secondary outcomes
Rate of Preterm birth
Time frame: <24, <32, <34 and <37 weeks
Rate of Premature rupture of membranes
Time frame: Up to 42 weeks of pregnancy
Gestational age at delivery
Time frame: At delivery
Days on ventilation support
Time frame: Up to 3 months corrected age
Days in NICU
Time frame: Up to 3 months corrected age
Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score
Time frame: Up to 3 months corrected age
Rate of maternal outcomes
Time frame: Up to 3 months corrected age
Adverse neonatal outcome
Time frame: Up to 3 months corrected age
Number of neonates with bronchopulmonary dysplasia
Time frame: Up to 3 months corrected age
Number of neonates with periventricular leucomalacia > grade 1
Time frame: Up to 3 months corrected age
Number of neonates with intraventricular hemorrhage > grade 2
Time frame: Up to 3 months corrected age
Number of neonates with necrotizing enterocolitis > stage 2
Time frame: Up to 3 months corrected age
Number of neonates with retinopathy of prematurity > stage 2
Time frame: Up to 3 months corrected age
Number of neonates with proven sepsis
Time frame: Up to 3 months corrected age
Perinatal death
Time frame: Up to 3 months corrected age
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 13 Nov 2023.
- Derived from this study: PubMed 38729756van Gils L, de Boer MA, Bosmans J, Duijnhoven R, Schoenmakers S, Derks JB, Prins JR, Al-Nasiry S, Lutke Holzik M, Lopriore E, van Drongelen J, Knol MH, van Laar JOEH, Jacquemyn Y, van Holsbeke C, Dehaene I, Lewi L, van der Merwe H, Gyselaers W, Obermann-Borst SA, Holthuis M, Mol BW, Pajkrt E, Oudijk MA. Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies. BMJ Open. 2024 May 10;14(5):e081561. doi: 10.1136/bmjopen-2023-081561.
- Individual participant dataSharing planned: Yes. The manuscript will be published in an Open Access journal that provides a PID (e.g., a DOI or URN)
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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.
Martijn A Oudijk, MD, PhD, Prof contact
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal cerclage in people with Preterm Birth, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 13 sites in 2 countries.
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 0 inclusion and 6 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Belgium. 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 Lissa van gils, MD (+31642811240, TWINC@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of extreme preterm birth (time frame: <28 weeks of gestation). 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 NCT05968794, 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 13 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.