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NCT Number: NCT05968794

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Antwerpen, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal cerclage

Procedure

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 outcomes

  1. Rate of extreme preterm birth

    Time frame: <28 weeks of gestation

Secondary outcomes

  1. Rate of Preterm birth

    Time frame: <24, <32, <34 and <37 weeks

    Indicated and spontaneous

  2. Rate of Premature rupture of membranes

    Time frame: Up to 42 weeks of pregnancy

  3. Gestational age at delivery

    Time frame: At delivery

  4. Days on ventilation support

    Time frame: Up to 3 months corrected age

    Neonatal

  5. Days in NICU

    Time frame: Up to 3 months corrected age

    Neonatal

  6. Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score

    Time frame: 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.

  7. Rate of maternal outcomes

    Time frame: Up to 3 months corrected age

    Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery).

  8. Adverse neonatal outcome

    Time frame: 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)

  9. Number of neonates with bronchopulmonary dysplasia

    Time frame: Up to 3 months corrected age

  10. Number of neonates with periventricular leucomalacia > grade 1

    Time frame: Up to 3 months corrected age

  11. Number of neonates with intraventricular hemorrhage > grade 2

    Time frame: Up to 3 months corrected age

  12. Number of neonates with necrotizing enterocolitis > stage 2

    Time frame: Up to 3 months corrected age

  13. Number of neonates with retinopathy of prematurity > stage 2

    Time frame: Up to 3 months corrected age

  14. Number of neonates with proven sepsis

    Time frame: Up to 3 months corrected age

  15. Perinatal death

    Time frame: Up to 3 months corrected age

Other outcomes

  1. Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire'

    Time frame: 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.

  2. Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire'

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lissa van gils, MD

CONTACT

[email protected]

+31642811240

Martijn A Oudijk, MD, PhD, Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: TWIN Cerclage

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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