Clinical trial NCT05968794: Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Keywords: Preterm birth
Twin pregnancy
Cerclage
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-08-01
Enrollment: 238
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: International, multicenter randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Rate of extreme preterm birth
timeFrame: <28 weeks of gestation
Secondary outcomes:
measure: Rate of Preterm birth
timeFrame: <24, <32, <34 and <37 weeks
measure: Rate of Premature rupture of membranes
timeFrame: Up to 42 weeks of pregnancy
measure: Gestational age at delivery
timeFrame: At delivery
measure: Days on ventilation support
timeFrame: Up to 3 months corrected age
measure: Days in NICU
timeFrame: Up to 3 months corrected age
measure: Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score
timeFrame: Up to 3 months corrected age
measure: Rate of maternal outcomes
timeFrame: Up to 3 months corrected age
measure: Adverse neonatal outcome
timeFrame: Up to 3 months corrected age
measure: Number of neonates with bronchopulmonary dysplasia
timeFrame: Up to 3 months corrected age
measure: Number of neonates with periventricular leucomalacia > grade 1
timeFrame: Up to 3 months corrected age
measure: Number of neonates with intraventricular hemorrhage > grade 2
timeFrame: Up to 3 months corrected age
measure: Number of neonates with necrotizing enterocolitis > stage 2
timeFrame: Up to 3 months corrected age
measure: Number of neonates with retinopathy of prematurity > stage 2
timeFrame: Up to 3 months corrected age
measure: Number of neonates with proven sepsis
timeFrame: Up to 3 months corrected age
measure: Perinatal death
timeFrame: Up to 3 months corrected age
Other outcomes:
measure: Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire'
timeFrame: Up to one week after labour and up to 3 months corrected age
measure: Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire'
timeFrame: Up to one week after labour and up to 3 months corrected age
Locations:
city: Antwerpen
country: Belgium
facility: University Medical Center Antwerpen
city: Brugge
country: Belgium
facility: University Medical Center Sint-Lucas Brugge
city: Genk
country: Belgium
facility: Hospital Oost-Limburg Genk
city: Gent
country: Belgium
facility: University Medical Center Gent
city: Leuven
country: Belgium
facility: University Medical Center Leuven
city: Amsterdam
country: Netherlands
facility: University Medical Center Amsterdam
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: University Medical Center Leiden
city: Maastricht
country: Netherlands
facility: University Medical Center Maastricht
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medical Centre
Study officials:
References: