Cerclage After Full Dilatation Caesarean Section (CRAFT)

An Investigation Into the Role of Previous in Labour Caesarean Section in Future Preterm Birth Risk and Management Strategies

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Preterm Premature Rupture of Membrane; Preterm Spontaneous Labor With Preterm Delivery
• Intervention / Treatment: Procedure: Insertion of transvaginal cerclage

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnieszka Glazewska-Hallin; Phone Number: 8151 020 7188; Email: agnieszka.glazewska-hallin@kcl.ac.uk
• Study Contact Backup: Name: Michael Waring; Phone Number: michael.waring@kcl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's and St Thomas' Hospital NHS Foundation Trust
    • Contact: Agnieszka Glazewska-Hallin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CRAFT-OBS: Number of participants with spontaneous preterm birth rate < 37 weeks gestation	Up to 42 weeks
CRAFT-RCT: Number of participants with spontaneous preterm birth <34 weeks gestation	Up to 42 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 48 weeks
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)		Up to 48 weeks
CRAFT-OBS: Number of participants who deliver <34 weeks gestation		Up to 42 weeks
CRAFT-OBS: Gestation at delivery	The proportion of participants who delivery at each gestation of completed weeks	Up to 42 weeks
CRAFT-OBS: Late miscarriage (14+0-23+6 weeks) rate		Up to 42 weeks
CRAFT-OBS: Any cervical length measurements taken antenatally		Up to 42 weeks
CRAFT-OBS: Number of antenatal hospital appointments		Up to 42 weeks
CRAFT-OBS: Number of hospital admissions		Up to 42 weeks
CRAFT-OBS: cervicovaginal fetal fibronectin protein levels taken at any gestation if taken		Up to 42 weeks
CRAFT-OBS: Number of ultrasound indicated antenatal interventions		Up to 42 weeks
CRAFT-OBS: Predictive modelling (QUIPP app) to evaluate the ability of CL and fFN to determine risk of preterm birth <34 and <37 weeks		Up to 42 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	Up to 48 weeks
CRAFT-RCT: Number of participants with an adverse perinatal outcome		Up to 48 weeks
CRAFT-RCT: Gestation at delivery	Proportion of participants who deliver at each gestation of completed weeks	Up to 42 weeks
CRAFT-RCT: Number of women needing insertion of a rescue cerclage (done when membranes exposed or bulging)		Up to 30 weeks
CRAFT-RCT: Time between intervention and delivery.		Up to 42 weeks
CRAFT-RCT - Health costs at 28 days post-delivery.		Up to 48 weeks
CRAFT-IMG: Evidence of cervical injury	Size of any cervical lesion and its location seen on MRI or ultrasound scans	Up to 40 weeks

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London; University College, London

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 261294; 42833 (Other Identifier: CPMS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Study Protocol
   Information identifier: IRAS 261294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No