NCT05968794

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
May 2023Dec 2028

First Submitted

Initial submission to the registry

April 22, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4.6 years

First QC Date

April 22, 2023

Last Update Submit

November 9, 2023

Conditions

Preterm Birth

Keywords

Preterm birthTwin pregnancyCerclage

Outcome Measures

Primary Outcomes (1)

  • Rate of extreme preterm birth

    <28 weeks of gestation

Secondary Outcomes (15)

  • Rate of Preterm birth

    <24, <32, <34 and <37 weeks

  • 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

  • Days in NICU

    Up to 3 months corrected age

  • +10 more secondary outcomes

Other Outcomes (2)

  • Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire'

    Up to one week after labour and up to 3 months corrected age

  • Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire'

    Up to one week after labour and up to 3 months corrected age

Study Arms (2)

Cerclage

EXPERIMENTAL

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.

Procedure: Vaginal cerclage

Standard care

NO INTERVENTION

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.

Interventions

Vaginal cerclagePROCEDURE

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.

Cerclage

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • an asymptomatic short cervix at routine ultrasound investigation (below 24 weeks of gestation) OR
  • cervical dilatation (below 24 weeks of gestation)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Medical Center Antwerpen

Antwerp, Belgium

NOT YET RECRUITING

University Medical Center Sint-Lucas Brugge

Bruges, Belgium

NOT YET RECRUITING

Hospital Oost-Limburg Genk

Genk, Belgium

NOT YET RECRUITING

University Medical Center Gent

Ghent, Belgium

NOT YET RECRUITING

University Medical Center Leuven

Leuven, Belgium

NOT YET RECRUITING

University Medical Center Amsterdam

Amsterdam, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

NOT YET RECRUITING

University Medical Center Leiden

Leiden, Netherlands

NOT YET RECRUITING

University Medical Center Maastricht

Maastricht, Netherlands

NOT YET RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

NOT YET RECRUITING

Erasmus Medical Centre

Rotterdam, Netherlands

NOT YET RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

NOT YET RECRUITING

Maxima Medical Centre

Veldhoven, Netherlands

NOT YET RECRUITING

Related Publications (1)

  • van Gils L, de Boer MA, Bosmans J, Duijnhoven R, Schoenmakers S, Derks JB, Prins JR, Al-Nasiry S, Lutke Holzik M, Lopriore E, van Drongelen J, Knol MH, van Laar JOEH, Jacquemyn Y, van Holsbeke C, Dehaene I, Lewi L, van der Merwe H, Gyselaers W, Obermann-Borst SA, Holthuis M, Mol BW, Pajkrt E, Oudijk MA. Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies. BMJ Open. 2024 May 10;14(5):e081561. doi: 10.1136/bmjopen-2023-081561.

    PMID: 38729756DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Lissa van gils, MD

CONTACT

+31642811240TWINC@amsterdamumc.nl

Martijn A Oudijk, MD, PhD, Prof

CONTACT

TWINC@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and investigators will not be blinded for the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: International, multicenter randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.dr.

Study Record Dates

First Submitted

April 22, 2023

First Posted

August 1, 2023

Study Start

May 15, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The manuscript will be published in an Open Access journal that provides a PID (e.g., a DOI or URN)

Shared Documents
STUDY PROTOCOL

Locations

BE(5)NL(8)