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

Preterm Birth Clinical Trial

— TWIN Cerclage  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968794
• Other study ID #: TwinC
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: December 1, 2028

Study information

• Verified date: November 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Lissa van gils, MD
• Phone: +31642811240
• Email: TWINC[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: December 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Belgium	University Medical Center Antwerpen	Antwerpen
Belgium	University Medical Center Sint-Lucas Brugge	Brugge
Belgium	Hospital Oost-Limburg Genk	Genk
Belgium	University Medical Center Gent	Gent
Belgium	University Medical Center Leuven	Leuven
Netherlands	University Medical Center Amsterdam	Amsterdam
Netherlands	University Medical Center Groningen	Groningen
Netherlands	University Medical Center Leiden	Leiden
Netherlands	University Medical Center Maastricht	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Erasmus Medical Centre	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht
Netherlands	Maxima Medical Centre	Veldhoven

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	ZonMw: The Netherlands Organisation for Health Research and Development

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire'	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.	Up to one week after labour and up to 3 months corrected age
Other	Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire'	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.	Up to one week after labour and up to 3 months corrected age
Primary	Rate of extreme preterm birth		<28 weeks of gestation
Secondary	Rate of Preterm birth	Indicated and spontaneous	<24, <32, <34 and <37 weeks
Secondary	Rate of Premature rupture of membranes		Up to 42 weeks of pregnancy
Secondary	Gestational age at delivery		At delivery
Secondary	Days on ventilation support	Neonatal	Up to 3 months corrected age
Secondary	Days in NICU	Neonatal	Up to 3 months corrected age
Secondary	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.	Up to 3 months corrected age
Secondary	Rate of maternal outcomes	Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery).	Up to 3 months corrected age
Secondary	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)	Up to 3 months corrected age
Secondary	Number of neonates with bronchopulmonary dysplasia		Up to 3 months corrected age
Secondary	Number of neonates with periventricular leucomalacia > grade 1		Up to 3 months corrected age
Secondary	Number of neonates with intraventricular hemorrhage > grade 2		Up to 3 months corrected age
Secondary	Number of neonates with necrotizing enterocolitis > stage 2		Up to 3 months corrected age
Secondary	Number of neonates with retinopathy of prematurity > stage 2		Up to 3 months corrected age
Secondary	Number of neonates with proven sepsis		Up to 3 months corrected age
Secondary	Perinatal death		Up to 3 months corrected age