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Cerclage After Full Dilatation Caesarean Section (CRAFT)

Primary Purpose

Preterm Birth, Preterm Premature Rupture of Membrane, Preterm Spontaneous Labor With Preterm Delivery

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Insertion of transvaginal cerclage
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

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

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.

Sites / Locations

  • Guy's and St Thomas' Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Transvaginal cerclage

Active monitoring

Arm Description

Outcomes

Primary Outcome Measures

CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation

Secondary Outcome Measures

CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.
We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.
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)
CRAFT-OBS: Number of participants who deliver <34 weeks gestation
CRAFT-OBS: Gestation at delivery
The proportion of participants who delivery at each gestation of completed weeks
CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate
CRAFT-OBS: Any cervical length measurements taken antenatally
CRAFT-OBS: Number of antenatal hospital appointments
CRAFT-OBS: Number of hospital admissions
CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken
CRAFT-OBS: Number of ultrasound indicated antenatal interventions
CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks
CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies
COPOP core outcomes
CRAFT-RCT: Number of participants with an adverse perinatal outcome
CRAFT-RCT: Gestation at delivery
Proportion of participants who deliver at each gestation of completed weeks
CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)
CRAFT-RCT: Time between intervention and delivery.
CRAFT-RCT - Health costs at 28 days post-delivery.
CRAFT-IMG: Evidence of cervical injury
Size of any cervical lesion and its location seen on MRI or ultrasound scans

Full Information

First Posted
September 26, 2019
Last Updated
July 27, 2021
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London, University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT04110704
Brief Title
Cerclage After Full Dilatation Caesarean Section
Acronym
CRAFT
Official Title
An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London, University College, London

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Preterm Premature Rupture of Membrane, Preterm Spontaneous Labor With Preterm Delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transvaginal cerclage
Arm Type
Active Comparator
Arm Title
Active monitoring
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Insertion of transvaginal cerclage
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation
Time Frame
Up to 42 weeks
Title
CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation
Time Frame
Up to 42 weeks
Secondary Outcome Measure Information:
Title
CRAFT-OBS: Short-term pregnancy and neonatal outcomes, including a composite of neonatal death and morbidity.
Description
We will assess the number of antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services.
Time Frame
Up to 48 weeks
Title
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
Title
CRAFT-OBS: Number of participants who deliver <34 weeks gestation
Time Frame
Up to 42 weeks
Title
CRAFT-OBS: Gestation at delivery
Description
The proportion of participants who delivery at each gestation of completed weeks
Time Frame
Up to 42 weeks
Title
CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate
Time Frame
Up to 42 weeks
Title
CRAFT-OBS: Any cervical length measurements taken antenatally
Time Frame
Up to 42 weeks
Title
CRAFT-OBS: Number of antenatal hospital appointments
Time Frame
Up to 42 weeks
Title
CRAFT-OBS: Number of hospital admissions
Time Frame
Up to 42 weeks
Title
CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken
Time Frame
Up to 42 weeks
Title
CRAFT-OBS: Number of ultrasound indicated antenatal interventions
Time Frame
Up to 42 weeks
Title
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
Title
CRAFT-OBS: Number of participants with other maternal and fetal morbidities, as per COPOP core outcome set for preterm birth intervention studies
Description
COPOP core outcomes
Time Frame
Up to 48 weeks
Title
CRAFT-RCT: Number of participants with an adverse perinatal outcome
Time Frame
Up to 48 weeks
Title
CRAFT-RCT: Gestation at delivery
Description
Proportion of participants who deliver at each gestation of completed weeks
Time Frame
Up to 42 weeks
Title
CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)
Time Frame
Up to 30 weeks
Title
CRAFT-RCT: Time between intervention and delivery.
Time Frame
Up to 42 weeks
Title
CRAFT-RCT - Health costs at 28 days post-delivery.
Time Frame
Up to 48 weeks
Title
CRAFT-IMG: Evidence of cervical injury
Description
Size of any cervical lesion and its location seen on MRI or ultrasound scans
Time Frame
Up to 40 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Glazewska-Hallin
Phone
020 7188
Ext
8151
Email
agnieszka.glazewska-hallin@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Waring
Phone
michael.waring@kcl.ac.uk
Facility Information:
Facility Name
Guy's and St Thomas' Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Glazewska-Hallin

12. IPD Sharing Statement

Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://preview-kcl.cloud.contensis.com/Preview/1/research/project?id=478a6e61-4446-4a12-945e-c41a3879371d
Available IPD/Information Identifier
IRAS 261294

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Cerclage After Full Dilatation Caesarean Section

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