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

Primary Purpose

Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vaginal cerclage
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth focused on measuring Preterm birth, Twin pregnancy, Cerclage

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Medical Center Antwerpen
  • University Medical Center Sint-Lucas Brugge
  • Hospital Oost-Limburg Genk
  • University Medical Center Gent
  • University Medical Center Leuven
  • University Medical Center AmsterdamRecruiting
  • University Medical Center Groningen
  • University Medical Center Leiden
  • University Medical Center Maastricht
  • Radboud University Medical Center
  • Erasmus Medical Centre
  • University Medical Center Utrecht
  • Maxima Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cerclage

Standard care

Arm Description

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.

The comparator will be standard treatment according to the current Dutch (NVOG) guideline from 2018, which is to not perform or offer an intervention such as vaginal cerclage. This is in line with the standard care in the participating hospitals in Belgium.

Outcomes

Primary Outcome Measures

Rate of extreme preterm birth

Secondary Outcome Measures

Rate of Preterm birth
Indicated and spontaneous
Rate of Premature rupture of membranes
Gestational age at delivery
Days on ventilation support
Neonatal
Days in NICU
Neonatal
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.
Rate of maternal outcomes
Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery).
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)
Number of neonates with bronchopulmonary dysplasia
Number of neonates with periventricular leucomalacia > grade 1
Number of neonates with intraventricular hemorrhage > grade 2
Number of neonates with necrotizing enterocolitis > stage 2
Number of neonates with retinopathy of prematurity > stage 2
Number of neonates with proven sepsis
Perinatal death

Full Information

First Posted
April 22, 2023
Last Updated
July 28, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05968794
Brief Title
Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
January 1, 2028 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm birth, Twin pregnancy, Cerclage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
International, multicenter randomized controlled trial
Masking
None (Open Label)
Masking Description
Participants and investigators will not be blinded for the intervention.
Allocation
Randomized
Enrollment
238 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerclage
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The comparator will be standard treatment according to the current Dutch (NVOG) guideline from 2018, which is to not perform or offer an intervention such as vaginal cerclage. This is in line with the standard care in the participating hospitals in Belgium.
Intervention Type
Procedure
Intervention Name(s)
Vaginal cerclage
Intervention Description
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 Outcome Measure Information:
Title
Rate of extreme preterm birth
Time Frame
<28 weeks of gestation
Secondary Outcome Measure Information:
Title
Rate of Preterm birth
Description
Indicated and spontaneous
Time Frame
<24, <32, <34 and <37 weeks
Title
Rate of Premature rupture of membranes
Time Frame
Up to 42 weeks of pregnancy
Title
Gestational age at delivery
Time Frame
At delivery
Title
Days on ventilation support
Description
Neonatal
Time Frame
Up to 3 months corrected age
Title
Days in NICU
Description
Neonatal
Time Frame
Up to 3 months corrected age
Title
Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score
Description
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
Title
Rate of maternal outcomes
Description
Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery).
Time Frame
Up to 3 months corrected age
Title
Adverse neonatal outcome
Description
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
Title
Number of neonates with bronchopulmonary dysplasia
Time Frame
Up to 3 months corrected age
Title
Number of neonates with periventricular leucomalacia > grade 1
Time Frame
Up to 3 months corrected age
Title
Number of neonates with intraventricular hemorrhage > grade 2
Time Frame
Up to 3 months corrected age
Title
Number of neonates with necrotizing enterocolitis > stage 2
Time Frame
Up to 3 months corrected age
Title
Number of neonates with retinopathy of prematurity > stage 2
Time Frame
Up to 3 months corrected age
Title
Number of neonates with proven sepsis
Time Frame
Up to 3 months corrected age
Title
Perinatal death
Time Frame
Up to 3 months corrected age
Other Pre-specified Outcome Measures:
Title
Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire'
Description
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.
Time Frame
Up to one week after labour and up to 3 months corrected age
Title
Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire'
Description
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.
Time Frame
Up to one week after labour and up to 3 months corrected age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lissa van gils, MD
Phone
+31642811240
Email
TWINC@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Martijn A Oudijk, MD, PhD, Prof
Email
TWINC@amsterdamumc.nl
Facility Information:
Facility Name
University Medical Center Antwerpen
City
Antwerpen
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Y Jacquemyn, Prof. Dr.
Facility Name
University Medical Center Sint-Lucas Brugge
City
Brugge
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C van Holsbeke, dr
Facility Name
Hospital Oost-Limburg Genk
City
Genk
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W Gyselaers, Prof.Dr.
Facility Name
University Medical Center Gent
City
Gent
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I Dehaene, Dr.
Facility Name
University Medical Center Leuven
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L Lewi, Dr
Facility Name
University Medical Center Amsterdam
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.A. Oudijk, Prof.Dr.
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.R. Prins, Dr
Facility Name
University Medical Center Leiden
City
Leiden
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E.M. Lutke-Holzik, Dr
Facility Name
University Medical Center Maastricht
City
Maastricht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Al-Nassiry, Dr
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J van Drongelen, Dr
Facility Name
Erasmus Medical Centre
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Schoenmakers, Dr
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J.B Derks, Dr
Facility Name
Maxima Medical Centre
City
Veldhoven
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J van Laar, Dr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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