xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968794</url>
    </required_header>
    <id_info>
      <org_study_id>TwinC</org_study_id>
      <nct_id>NCT05968794</nct_id>
    </id_info>
    <brief_title>Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation</brief_title>
    <acronym>TWIN Cerclage</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess the effectiveness of a cerclage in women with a&#xD;
        twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard&#xD;
        treatment (no cerclage) in the prevention of extreme preterm birth &lt; 28 weeks of gestational&#xD;
        age.&#xD;
  &#xD;
        The main question it aims to answer is: What is the effectiveness of a cerclage in women with&#xD;
        a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard&#xD;
        treatment (no cerclage) in the prevention of extreme preterm birth &lt; 28 weeks of gestational&#xD;
        age?&#xD;
  &#xD;
        Participants will be randomly assigned to the intervention (cerclage) or comparison (no&#xD;
        cerclage) group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: In the Netherlands, 250 women with a twin pregnancy deliver at &lt; 28 weeks per&#xD;
        year, resulting in 157 perinatal deaths. A vaginal cerclage could be an effective surgical&#xD;
        method to reduce cervical insufficiency and with that preterm birth, but the evidence&#xD;
        regarding its effectiveness on extreme preterm birth and (long term) neonatal outcome is&#xD;
        lacking.&#xD;
  &#xD;
        Objective: To assess the effectiveness of a cerclage in women with a twin pregnancy with a&#xD;
        midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage)&#xD;
        in the prevention of extreme preterm birth &lt; 28 weeks of gestational age.&#xD;
  &#xD;
        Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
        relatedness: A vaginal cerclage is a minor and safe surgical procedure commonly performed in&#xD;
        singleton pregnancies with a short cervix and a previous preterm birth in all the&#xD;
        participating centers, thus there is experience in the participating hospitals. The results&#xD;
        of this study will show whether a vaginal cerclage reduces extreme preterm birth in women&#xD;
        with twin pregnancy and a short cervix, and its accompanying perinatal complications. If&#xD;
        proven effective, the implementation of this intervention will have a huge impact on the&#xD;
        lifelong health of these children and their families.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>International, multicenter randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Participants and investigators will not be blinded for the intervention.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of extreme preterm birth</measure>
      <time_frame>&lt;28 weeks of gestation</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of Preterm birth</measure>
      <time_frame>&lt;24, &lt;32, &lt;34 and &lt;37 weeks</time_frame>
      <description>Indicated and spontaneous</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Premature rupture of membranes</measure>
      <time_frame>Up to 42 weeks of pregnancy</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gestational age at delivery</measure>
      <time_frame>At delivery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days on ventilation support</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
      <description>Neonatal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days in NICU</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
      <description>Neonatal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of maternal outcomes</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
      <description>Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse neonatal outcome</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
      <description>A composite for adverse neonatal outcome (including bronchopulmonary dysplasia, periventricular leucomalacia &gt; grade 1, intraventricular hemorrhage &gt; grade 2, necrotizing enterocolitis &gt; stage 2, retinopathy of prematurity &gt; stage 2, proven sepsis and perinatal death)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of neonates with bronchopulmonary dysplasia</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of neonates with periventricular leucomalacia &gt; grade 1</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of neonates with intraventricular hemorrhage &gt; grade 2</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of neonates with necrotizing enterocolitis &gt; stage 2</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of neonates with retinopathy of prematurity &gt; stage 2</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of neonates with proven sepsis</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perinatal death</measure>
      <time_frame>Up to 3 months corrected age</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire'</measure>
      <time_frame>Up to one week after labour and up to 3 months corrected age</time_frame>
      <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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire'</measure>
      <time_frame>Up to one week after labour and up to 3 months corrected age</time_frame>
      <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.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">238</enrollment>
    <condition>Preterm Birth</condition>
    <arm_group>
      <arm_group_label>Cerclage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Vaginal cerclage</intervention_name>
      <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.</description>
      <arm_group_label>Cerclage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Women (&gt; 16 years of age) with a twin pregnancy and:&#xD;
  &#xD;
            -  an asymptomatic short cervix at routine ultrasound investigation (below 24 weeks of&#xD;
               gestation) OR&#xD;
  &#xD;
            -  cervical dilatation (below 24 weeks of gestation)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women with a mono-amniotic twin pregnancy&#xD;
  &#xD;
            -  Women with twin pregnancy in which one or both children are diagnosed with a major&#xD;
               structural, congenital or chromosomal abnormality that is likely to influence the&#xD;
               composite adverse neonatal outcome.&#xD;
  &#xD;
            -  Women with dilatation of the cervix and signs of clinical intra-uterine infection,&#xD;
               defined by the presence of fever ≥ 38 degrees Celsius.&#xD;
  &#xD;
            -  Women with overt symptoms of preterm labour at time of measurement of short cervix&#xD;
               (regular contractions, PPROM, recurrent blood loss).&#xD;
  &#xD;
            -  Women with a placenta previa, defined as a placenta position covering the internal&#xD;
               ostium of the cervix.&#xD;
  &#xD;
            -  Women who do not master the Dutch of English language and therefore not able to give&#xD;
               written consent&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lissa van gils, MD</last_name>
      <phone>+31642811240</phone>
      <email>TWINC@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Martijn A Oudijk, MD, PhD, Prof</last_name>
      <email>TWINC@amsterdamumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Medical Center Antwerpen</name>
        <address>
          <city>Antwerpen</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Y Jacquemyn, Prof. Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Sint-Lucas Brugge</name>
        <address>
          <city>Brugge</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>C van Holsbeke, dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Oost-Limburg Genk</name>
        <address>
          <city>Genk</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>W Gyselaers, Prof.Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Gent</name>
        <address>
          <city>Gent</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>I Dehaene, Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Leuven</name>
        <address>
          <city>Leuven</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>L Lewi, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Amsterdam</name>
        <address>
          <city>Amsterdam</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>M.A. Oudijk, Prof.Dr.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Groningen</name>
        <address>
          <city>Groningen</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>J.R. Prins, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Leiden</name>
        <address>
          <city>Leiden</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>E.M. Lutke-Holzik, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Maastricht</name>
        <address>
          <city>Maastricht</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>S Al-Nassiry, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Radboud University Medical Center</name>
        <address>
          <city>Nijmegen</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>J van Drongelen, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Erasmus Medical Centre</name>
        <address>
          <city>Rotterdam</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>S Schoenmakers, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Medical Center Utrecht</name>
        <address>
          <city>Utrecht</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>J.B Derks, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Maxima Medical Centre</name>
        <address>
          <city>Veldhoven</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>J van Laar, Dr</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Martijn A. Oudijk, MD, PhD</investigator_full_name>
      <investigator_title>Prof.dr.</investigator_title>
    </responsible_party>
    <keyword>Preterm birth</keyword>
    <keyword>Twin pregnancy</keyword>
    <keyword>Cerclage</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premature Birth</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968794
  org study id: TwinC
  nct id: NCT05968794
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: International, multicenter randomized controlled trial
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Participants and investigators will not be blinded for the intervention.
  measure: Rate of extreme preterm birth
  time frame: <28 weeks of gestation
  measure: Rate of Preterm birth
  time frame: <24, <32, <34 and <37 weeks
  description: Indicated and spontaneous
  measure: Rate of Premature rupture of membranes
  time frame: Up to 42 weeks of pregnancy
  measure: Gestational age at delivery
  time frame: At delivery
  measure: Days on ventilation support
  time frame: Up to 3 months corrected age
  description: Neonatal
  measure: Days in NICU
  time frame: Up to 3 months corrected age
  description: Neonatal
  measure: Maternal quality of life assessed by the 'European Quality of life 5-Dimension 5-Level' score
  time frame: Up to 3 months corrected age
  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.
  measure: Rate of maternal outcomes
  time frame: Up to 3 months corrected age
  description: Sepsis, need for antibiotics, need to remove cerclage in operation room, mode of delivery (% caesarean delivery).
  measure: Adverse neonatal outcome
  time frame: Up to 3 months corrected age
  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)
  measure: Number of neonates with bronchopulmonary dysplasia
  time frame: Up to 3 months corrected age
  measure: Number of neonates with periventricular leucomalacia > grade 1
  time frame: Up to 3 months corrected age
  measure: Number of neonates with intraventricular hemorrhage > grade 2
  time frame: Up to 3 months corrected age
  measure: Number of neonates with necrotizing enterocolitis > stage 2
  time frame: Up to 3 months corrected age
  measure: Number of neonates with retinopathy of prematurity > stage 2
  time frame: Up to 3 months corrected age
  measure: Number of neonates with proven sepsis
  time frame: Up to 3 months corrected age
  measure: Perinatal death
  time frame: Up to 3 months corrected age
  measure: Healthcare costs assessed by the 'iMTA Medical Consumption Questionnaire'
  time frame: Up to one week after labour and up to 3 months corrected age
  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.
  measure: Healthcare costs assessed by the 'iMTA Productivity Cost Questionnaire'
  time frame: Up to one week after labour and up to 3 months corrected age
  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.
  arm group label: Cerclage
  arm group type: Experimental
  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 group label: Standard care
  arm group type: No Intervention
  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: Vaginal cerclage
  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 group label: Cerclage
  criteria: 
  gender: Female
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lissa van gils, MD
  phone: +31642811240
  email: TWINC@amsterdamumc.nl
  last name: Martijn A Oudijk, MD, PhD, Prof
  email: TWINC@amsterdamumc.nl
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Belgium
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Martijn A. Oudijk, MD, PhD
  investigator title: Prof.dr.
  mesh term: Premature Birth
  sharing ipd: Undecided