Cerclage After Full Dilatation Caesarean Section

Preterm Birth Clinical Trial

— CRAFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110704
• Other study ID #: 261294
• Secondary ID: 42833
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: July 2021
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Agnieszka Glazewska-Hallin
• Phone: 020 7188
• Email: agnieszka.glazewska-hallin[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Birth
• Preterm Premature Rupture of Membrane
• Preterm Spontaneous Labor With Preterm Delivery
• Rupture

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' Hospital NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London, University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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