Cerclage After Full Dilatation Caesarean Section (CRAFT)

Guy's and St Thomas' NHS Foundation Trust

Status

Unknown

Conditions

Preterm Premature Rupture of Membrane

Preterm Spontaneous Labor With Preterm Delivery

Preterm Birth

Treatments

Procedure: Insertion of transvaginal cerclage

Study type

Interventional

Funder types

Other

Identifiers

NCT04110704

42833 (Other Identifier)

261294

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

Female

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.