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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal cerclage | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of extreme preterm birth | <28 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Preterm birth | Indicated and spontaneous | <24, <32, <34 and <37 weeks |
| Rate of Premature rupture of membranes | Up to 42 weeks of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire' | Costs will be measured from a societal perspective using a web-based questionnaires based on the 'iMTA Medical Consumption Questionnaire'. The scoring involves quantifying the reported healthcare resource use based on the responses provided by the participants. The questionnaire collects information about various types of healthcare services and resources, such as hospitalizations, outpatient visits and medication use. |
Inclusion Criteria: Women (> 16 years of age) with a twin pregnancy and:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lissa van gils, MD | Contact | +31642811240 | TWINC@amsterdamumc.nl | |
| Martijn A Oudijk, MD, PhD, Prof | Contact | TWINC@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Antwerpen | Not yet recruiting | Antwerp | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38729756 | Derived | 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. |
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The manuscript will be published in an Open Access journal that provides a PID (e.g., a DOI or URN)
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International, multicenter randomized controlled trial
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Participants and investigators will not be blinded for the intervention.
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| Gestational age at delivery | At delivery |
| Days on ventilation support | Neonatal | Up to 3 months corrected age |
| Days in NICU | Neonatal | 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. | 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). | 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) | Up to 3 months corrected age |
| Number of neonates with bronchopulmonary dysplasia | Up to 3 months corrected age |
| Number of neonates with periventricular leucomalacia > grade 1 | Up to 3 months corrected age |
| Number of neonates with intraventricular hemorrhage > grade 2 | Up to 3 months corrected age |
| Number of neonates with necrotizing enterocolitis > stage 2 | Up to 3 months corrected age |
| Number of neonates with retinopathy of prematurity > stage 2 | Up to 3 months corrected age |
| Number of neonates with proven sepsis | Up to 3 months corrected age |
| Perinatal death | Up to 3 months corrected age |
| Up to one week after labour and up to 3 months corrected age |
| Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire' | Costs will be measured using a web-based questionnaires based on the 'iMTA Productivity Cost Questionnaire'. It collects information on the duration and frequency of productivity loss, as well as associated costs.The questionnaire consists of multiple sections and items that gather data on work-related activities, job characteristics, and productivity impact. Respondents are asked to report on their own productivity or that of a specific population (e.g., patients, caregivers) over a defined period. | Up to one week after labour and up to 3 months corrected age |
| University Medical Center Sint-Lucas Brugge | Not yet recruiting | Bruges | Belgium |
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| Hospital Oost-Limburg Genk | Not yet recruiting | Genk | Belgium |
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| University Medical Center Gent | Not yet recruiting | Ghent | Belgium |
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| University Medical Center Leuven | Not yet recruiting | Leuven | Belgium |
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| University Medical Center Amsterdam | Recruiting | Amsterdam | Netherlands |
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| University Medical Center Groningen | Not yet recruiting | Groningen | Netherlands |
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| University Medical Center Leiden | Not yet recruiting | Leiden | Netherlands |
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| University Medical Center Maastricht | Not yet recruiting | Maastricht | Netherlands |
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| Radboud University Medical Center | Not yet recruiting | Nijmegen | Netherlands |
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| Erasmus Medical Centre | Not yet recruiting | Rotterdam | Netherlands |
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| University Medical Center Utrecht | Not yet recruiting | Utrecht | Netherlands |
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| Maxima Medical Centre | Not yet recruiting | Veldhoven | Netherlands |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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