Status:
UNKNOWN
Cerclage After Full Dilatation Caesarean Section
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
University College, London
Conditions:
Preterm Birth
Preterm Premature Rupture of Membrane
Eligibility:
FEMALE
16+ years
Phase:
NA
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 acqu...
Eligibility Criteria
Inclusion
- CRAFT-OBS
- 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
- 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.
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04110704
Start Date
October 2 2019
End Date
October 1 2022
Last Update
July 28 2021
Active Locations (1)
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1
Guy's and St Thomas' Hospital NHS Foundation Trust
London, United Kingdom, SE1 7EH