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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
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.
University Medical Center Antwerpen
Antwerp, Belgium
NOT_YET_RECRUITINGUniversity Medical Center Sint-Lucas Brugge
Bruges, Belgium
NOT_YET_RECRUITINGHospital Oost-Limburg Genk
Genk, Belgium
NOT_YET_RECRUITINGUniversity Medical Center Gent
Ghent, Belgium
NOT_YET_RECRUITINGUniversity Medical Center Leuven
Leuven, Belgium
NOT_YET_RECRUITINGUniversity Medical Center Amsterdam
Amsterdam, Netherlands
RECRUITINGUniversity Medical Center Groningen
Groningen, Netherlands
NOT_YET_RECRUITINGUniversity Medical Center Leiden
Leiden, Netherlands
NOT_YET_RECRUITINGUniversity Medical Center Maastricht
Maastricht, Netherlands
NOT_YET_RECRUITINGRadboud University Medical Center
Nijmegen, Netherlands
NOT_YET_RECRUITING...and 3 more locations
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
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