Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaginal cerclage.
- Who it may be relevant to
- Registry conditions: Preterm Birth. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure Vaginal cerclage
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.
Primary outcome measures
- Rate of extreme preterm birth [Time frame: <28 weeks of gestation]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion Criteria: Women (> 16 years of age) with a twin pregnancy and:
- an asymptomatic short cervix at routine ultrasound investigation (below 24 weeks of gestation) OR
- cervical dilatation (below 24 weeks of gestation)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 8 centers
- University Medical Center Amsterdam — Amsterdam
- University Medical Center Groningen — Groningen
- University Medical Center Leiden — Leiden
- University Medical Center Maastricht — Maastricht
- Radboud University Medical Center — Nijmegen
- Erasmus Medical Centre — Rotterdam
- University Medical Center Utrecht — Utrecht
- Maxima Medical Centre — Veldhoven
Belgium · 5 centers
- University Medical Center Antwerpen — Antwerp
- University Medical Center Sint-Lucas Brugge — Bruges
- Hospital Oost-Limburg Genk — Genk
- University Medical Center Gent — Ghent
- University Medical Center Leuven — Leuven
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 r PMID 38729756
Identifiers
NCT: NCT05968794 · TwinC