Preterm Birth
Conditions
Keywords
Preterm birth, Twin pregnancy, Cerclage
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.
Interventions
PROCEDUREVaginal 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.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and investigators will not be blinded for the intervention.
Intervention model description
International, multicenter randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of extreme preterm birth | <28 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Preterm birth | <24, <32, <34 and <37 weeks | Indicated and spontaneous |
| Rate of Premature rupture of membranes | Up to 42 weeks of pregnancy | — |
| Gestational age at delivery | At delivery | — |
| Days on ventilation support | Up to 3 months corrected age | Neonatal |
| Days in NICU | Up to 3 months corrected age | Neonatal |
| Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score | Up to 3 months corrected age | 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. |
| Rate of maternal outcomes | Up to 3 months corrected age | Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery). |
| Adverse neonatal outcome | Up to 3 months corrected age | 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) |
| Number of neonates with proven sepsis | Up to 3 months corrected age | — |
| Perinatal death | Up to 3 months corrected age | — |
| Number of neonates with bronchopulmonary dysplasia | Up to 3 months corrected age | — |
| Number of neonates with periventricular leucomalacia > grade 1 | Up to 3 months corrected age | — |
| Number of neonates with intraventricular hemorrhage > grade 2 | Up to 3 months corrected age | — |
| Number of neonates with necrotizing enterocolitis > stage 2 | Up to 3 months corrected age | — |
| Number of neonates with retinopathy of prematurity > stage 2 | Up to 3 months corrected age | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire' | Up to one week after labour and up to 3 months corrected age | 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. |
| Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire' | Up to one week after labour and up to 3 months corrected age | 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. |
Countries
Belgium, Netherlands
Contacts
Primary ContactLissa van gils, MD
Backup ContactMartijn A Oudijk, MD, PhD, Prof
Outcome results
None listed