CRAFT: Cerclarge after full dilatation caesarean section; an investigation into the role of previous in labour caesarean section in future preterm birth risk and potential management strategies

Current inclusion criteria as of 28/01/2020:

All CRAFT studies:

Pregnant women under 24+0 weeks’ gestation (or up to 36+6 weeks gestation for CRAFT-OBS) with a history of previous in-labour Caesarean section at term in any previous pregnancy

Ability to understand English (with or without interpreter)

Singleton pregnancy

Willing to give informed consent

CRAFT-OBS:

Pregnant women up until 36+6 weeks gestation who have had a previous emergency Caesarean section

CRAFT-RCT (discontinued August 2021):

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

Short cervix (< = 25mm) on transvaginal ultrasound scan

CRAFT-IMG:

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

Previous inclusion criteria:

All CRAFT studies:

Pregnant women under 24+0 weeks’ gestation with a history of previous caesarean section in labour

Ability to understand English (with or without interpreter)

Singleton pregnancy

Willing to give informed consent

CRAFT-OBS:

Pregnant women 14+0-23+6 weeks gestation who have had a previous emergency Caesarean section

CRAFT-RCT:

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

Short cervix (< = 25mm) on transvaginal ultrasound scan

CRAFT-IMG:

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

Current exclusion criteria as of 28/01/2020:

All CRAFT studies:

Under 16 years of age

Inability to give informed consent

Only previous caesarean section carried out before labour

CRAFT-RCT

Women with persistent fresh vaginal bleeding evident on speculum examination

Women with visible 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

Women who have any cerclage in situ

CRAFT-IMG:

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

Previous exclusion criteria:

All CRAFT studies:

Under 16 years of age

Inability to give informed consent

Previous caesarean section carried out before labour

Women recruited to studies with interventions of arabin pessary, progesterone, or cerclage, or if commenced on clinical grounds with management in the form of an arabin pessary, progesterone or cerclage will not be eligible

CRAFT-RCT

Women with persistent fresh vaginal bleeding evident on speculum examination

Women with visible 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:

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