Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation

Официальное название

The Effectiveness of Cerclage for the Reduction of Extreme Preterm Birth and Perinatal Mortality in Twin Pregnancies With a Short Cervix or Dilatation

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Rate of extreme preterm birth [Срок оценки: <28 weeks of gestation]

Вторичные конечные точки (12)

• Rate of Preterm birth [Срок оценки: <24, <32, <34 and <37 weeks]
• Rate of Premature rupture of membranes [Срок оценки: Up to 42 weeks of pregnancy]
• Gestational age at delivery [Срок оценки: At delivery]
• Days on ventilation support [Срок оценки: Up to 3 months corrected age]
• Days in NICU [Срок оценки: Up to 3 months corrected age]
• Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score [Срок оценки: Up to 3 months corrected age]
• Rate of maternal outcomes [Срок оценки: Up to 3 months corrected age]
• Adverse neonatal outcome [Срок оценки: Up to 3 months corrected age]
• Number of neonates with bronchopulmonary dysplasia [Срок оценки: Up to 3 months corrected age]
• Number of neonates with periventricular leucomalacia > grade 1 [Срок оценки: Up to 3 months corrected age]
• Number of neonates with intraventricular hemorrhage > grade 2 [Срок оценки: Up to 3 months corrected age]
• Number of neonates with necrotizing enterocolitis > stage 2 [Срок оценки: Up to 3 months corrected age]

Критерии участия

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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 8 центров

• 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

Бельгия · 5 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT05968794 · TwinC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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