ABOVE: Cerclage after Caesarea

Not Applicable

• Conditions: Preterm birth secondary to caesarean section; Pregnancy and Childbirth

• Registration Number: ISRCTN10977996
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-17
• Last Update Posted: 27 May 2024
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 243

Inclusion Criteria

Women will be eligible for the trial if they are:
1. Willing and able to give informed consent
2. Aged 16 years or above
3. Have had a previous term in-labour caesarean section (between 4 and 10 cm dilated) followed by an MTL (> 14 weeks) or preterm birth (<30 weeks)
4. Pregnant, but will be less than 14+0 weeks’ gestation at the time of the allocated intervention (Group A) OR
5. Not yet pregnant but considering a further pregnancy (Group B)

Exclusion Criteria

Potential participants will not be eligible for the trial if:
1. They are more than 14+0 weeks pregnant at the time of randomisation (as insertion of TAC is associated with higher risk beyond this gestation)
2. They already have a cerclage or (Arabin) pessary in situ
3. They are not planning another pregnancy
4. They have a history of preterm birth (spontaneous/iatrogenic) prior to the term emergency section
5. They are pregnant and expecting more than one baby (multiple pregnancy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified