Preterm birth secondary to caesarean section Pregnancy and Childbirth
Conditions
Interventions
ABOVE is a multi-centre randomized controlled trial comparing TAC or TVC as a preventative strategy for sPTB in women with a history of sPTB or MTL after an in-labour caesarean section.
Participants
Group A: in pregnancy and Group B: pre-conception.
160 participants with complete data in total (80/group) with a history of term CS in labour, followed by a subsequent pregnancy loss or sPTB (define
REC reference 22/ES/01
IRAS 308157). Women will be randomised to one of the two preventative treatments: 1) TAC, or 2) TVC
It is important to separately evaluate pre-conception and in-pregnancy TACs. The suture can be plac
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Age
16 Years to 65 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of mid-trimester pregnancy loss or spontaneous preterm birth before 30 weeks of gestation, collected from the patient's medical records | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal: 1. Admission to hospital for symptoms of threatened preterm labour 2. Administration of antenatal corticosteroids for fetal lung maturation 3. Administration of magnesium sulphate for fetal cerebral protection. 4. Transfer to other hospitals for neonatal cot availability (in-utero transfer) 5. Time between intervention and delivery 6. Requirement for additional emergency/rescue cerclage 7. Serious complications occurring as a result of trial intervention: bladder injury, bowel injury, intraoperative rupture of membranes, cervical tear, hysterectomy 8. Maternal sepsis 9. Admission to ITU 10. Maternal death Neonatal: 1. Gestation at birth 2. Birthweight 3. Apgar scores (if available) 4. Days before discharge home (up to 28 days) 5. Admission to neonatal unit 6. Neonatal infection 7. In utero fetal death after 14 weeks 8. Stillbirth 9. Neonatal death Collected from the patient's medical records at time of birth unless stated otherwise | — |
Countries
England, United Kingdom
Contacts
Public ContactAndrew;Laura Shennan;van der Krogt
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Outcome results
None listed