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Cerclage After Full Dilatation Caesarean Section (CRAFT)

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ClinicalTrials.gov Identifier: NCT04110704
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Collaborators:
King's College London
University College, London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth <34 weeks and <37 weeks.

CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation

CRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.


Condition or disease Intervention/treatment Phase
Preterm Birth Preterm Premature Rupture of Membrane Preterm Spontaneous Labor With Preterm Delivery Procedure: Insertion of transvaginal cerclage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Transvaginal cerclage Procedure: Insertion of transvaginal cerclage
Transvaginal cerclage is inserted in women with a high risk of preterm birth. However it is unknown whether this alongside cervical length monitoring improves the incidence of preterm birth. The cerclage is inserted under regional analgesia.

No Intervention: Active monitoring



Primary Outcome Measures :
  1. CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation [ Time Frame: Up to 42 weeks ]
  2. CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation [ Time Frame: Up to 42 weeks ]

Secondary Outcome Measures :
  1. CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity. [ Time Frame: Up to 48 weeks ]
    We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.

  2. CRAFT-OBS: Number of participants with adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) [ Time Frame: Up to 48 weeks ]
  3. CRAFT-OBS: Number of participants who deliver <34 weeks gestation [ Time Frame: Up to 42 weeks ]
  4. CRAFT-OBS: Gestation at delivery [ Time Frame: Up to 42 weeks ]
    The proportion of participants who delivery at each gestation of completed weeks

  5. CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate [ Time Frame: Up to 42 weeks ]
  6. CRAFT-OBS: Any cervical length measurements taken antenatally [ Time Frame: Up to 42 weeks ]
  7. CRAFT-OBS: Number of antenatal hospital appointments [ Time Frame: Up to 42 weeks ]
  8. CRAFT-OBS: Number of hospital admissions [ Time Frame: Up to 42 weeks ]
  9. CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken [ Time Frame: Up to 42 weeks ]
  10. CRAFT-OBS: Number of ultrasound indicated antenatal interventions [ Time Frame: Up to 42 weeks ]
  11. CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks [ Time Frame: Up to 42 weeks ]
  12. CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies [ Time Frame: Up to 48 weeks ]
    COPOP core outcomes

  13. CRAFT-RCT: Number of participants with an adverse perinatal outcome [ Time Frame: Up to 48 weeks ]
  14. CRAFT-RCT: Gestation at delivery [ Time Frame: Up to 42 weeks ]
    Proportion of participants who deliver at each gestation of completed weeks

  15. CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging) [ Time Frame: Up to 30 weeks ]
  16. CRAFT-RCT: Time between intervention and delivery. [ Time Frame: Up to 42 weeks ]
  17. CRAFT-RCT - Health costs at 28 days post-delivery. [ Time Frame: Up to 48 weeks ]
  18. CRAFT-IMG: Evidence of cervical injury [ Time Frame: Up to 40 weeks ]
    Size of any cervical lesion and its location seen on MRI or ultrasound scans



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

CRAFT-OBS

Inclusion Criteria:

  • Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour.
  • Singleton pregnancy.
  • Willing and able to give informed consent (with or without interpreter).

Exclusion Criteria:

  • Under 16 years of age.
  • Inability to give informed consent.
  • Previous caesarean section carried out before labour.
  • Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study

CRAFT-RCT:

Inclusion criteria:

  • Pregnant women up to 23+6 weeks gestation with a history of FDCS.
  • Short cervix (<=25mm) on transvaginal ultrasound scan.

Exclusion criteria:

  • Women with persistent fresh vaginal bleeding evident on speculum examination.
  • Women with visible fetal membranes evident on speculum examination or open cervix on ultrasound scan.
  • Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
  • Known significant congenital or structural or chromosomal fetal abnormality.
  • Suspected or proven rupture of the fetal membranes at the time of recruitment.

CRAFT-IMG

Inclusion criteria:

  • Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.

Exclusion criteria:

  • Contraindications to MRI, e.g. claustrophobia, BMI >40 kg/m2 (due to technical limitations of scanner) or a women with a non-MRI compatible metallic implant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110704


Contacts
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Contact: Agnieszka Glazewska-Hallin 020 7188 ext 8151 agnieszka.glazewska-hallin@kcl.ac.uk
Contact: Michael Waring michael.waring@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas' Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Agnieszka Glazewska-Hallin         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
University College, London
  Study Documents (Full-Text)

Documents provided by Guy's and St Thomas' NHS Foundation Trust:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: IRAS 261294

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04110704    
Other Study ID Numbers: 261294
42833 ( Other Identifier: CPMS )
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries