The OptiBreech Care Trial: a feasibility study for a pragmatic trial of care for women with a breech-presenting baby at term

King's College London0 个研究点目标入组 273 人开始时间: 2021年10月18日最近更新: 2024年1月15日

适应症

试验速览

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37967120/ Pilot (added 16/11/2023) 2023 Preprint results in https://doi.org/10.3310/nihropenres.13500.1 (added 04/01/2024)

•Current participant inclusion criteria as of 07/09/2023:
•1. Live, singleton pregnancy with a breech-presenting fetus confirmed by ultrasound scan
•2. Over 16 years of age
•3. Referred for specialist care for breech presentation antenatally from 32 weeks
•4. Breech presentation from 37 weeks discovered in labour
•5. Requesting or preferring a vaginal birth
•6. Giving informed consent to participate in contributing data
•7. Consent to randomisation to be offered new treatments that are being tested (only for pilot trial)
•Previous participant inclusion criteria:
•1. Live, singleton pregnancy with a breech-presenting fetus confirmed by ultrasound scan
•2. Over 16 years of age
•3. Referred for specialist care for breech presentation antenatally from 32 weeks
•4. Breech presentation from 37 weeks discovered in labour
•5. Requesting or preferring a vaginal birth
•6. Giving informed consent to participate in contributing data
•7. Consent to randomisation to be offered new treatments that are being tested

•1. Absolute reason for caesarean section already exists (e.g. placenta praevia major)
•2. Requesting a caesarean section prior to recruitment
•3. Multiple pregnancy
•4. Life-threatening congenital anomaly
•5. Not consenting to contribute data to the study
•6. Has already had an ECV attempt prior to recruitment
•7. Rhesus isoimmunisation
•8. Current or recent (less than 1 week) vaginal bleeding
•9. Evidence of antenatal fetal compromise, including abnormal electronic fetal monitoring
•10. Rupture of the membranes
•11. Hyperextended neck on ultrasound
•12. Estimated fetal weight less than 2000 g or less than 10th centile at recruitment
•13. Estimated fetal weight greater than 3800g or over 95th centile at recruitment
•14. Standing/footling presentation at the time of recruitment, defined as hips extended and breech not engaged
•15. Any indication at the time of recruitment for induction to be recommended prior to 41 weeks of pregnancy, e.g. gestational diabetes, obstetric cholestasis, advanced maternal age
•16. Breech diagnosed for the first time in labour
•17. Two or more previous caesarean sections

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