An interventional study of Vaginal cerclage in Preterm Birth, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 13 sites in 2 countries. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 238 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Inclusion Criteria: Women (> 16 years of age) with a twin pregnancy and:
Exclusion Criteria:
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.
Procedure: Vaginal cerclage
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.
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.
Rate of extreme preterm birth
Time frame: <28 weeks of gestation
Rate of Preterm birth
Indicated and spontaneous
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
Neonatal
Time frame: Up to 3 months corrected age
Days in NICU
Neonatal
Time frame: 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.
Time frame: 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).
Time frame: 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)
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
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.
Time frame: 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.
Time frame: Up to one week after labour and up to 3 months corrected age
Plan to share: Yes — The manuscript will be published in an Open Access journal that provides a PID (e.g., a DOI or URN)
Supporting information: Study protocol
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)