NCT04110704

Cerclage After Full Dilatation Caesarean Section

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Birth
• Preterm Premature Rupture of Membrane
• Preterm Spontaneous Labor With Preterm Delivery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-02
• Primary completion: 2022-04-01
• Completion: 2022-10-01
• First posted: 2019-10-01
• Last updated: 2021-07-28

Locations

1 site across 1 country: United Kingdom