Breech pregnancy Pregnancy and Childbirth Maternal care for breech presentation
Conditions
Interventions
Current interventions as of 07/09/2023:
Pilot trial (Pilot RCT stopped in June 2022 on advice of the Trial Steering Committee, due to lack of planned vaginal breech births among women
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 07/09/2023: Pilot RCT 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 6 months (randomised) and overall (non-randomised) 2. Acceptance rate recorded as the number of participants randomised to OptiBreech Care who plan a vaginal breech birth, and the number of participants randomised to the control who attempt an ECV, measured at the time of birth (randomised) 3. Attrition rate recorded as the number of participants who consent to participate who remain in the study until the end of follow-up at 4 months after birth 4. Long-term attrition rate recorded as the number of OptiBreech 1 participants who complete 1-year and 2-year follow-up surveys when invited 5. Fidelity to intervention recorded as the number of planned vaginal breech births (VBBs) attended by a proficient team member, measured at the time of birth 6. Costs to deliver the service recorded as the total number of days and nights spent on call to support planned VBBs in the trial by 6 months Previous primary outcome measures: 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 6 months (randomised) and overall (non-randomised) 2. Acceptance rate recorded as the number of participants randomised to OptiBreech Care who plan a vaginal breech birth, and the number of participants randomised to the control who attempt an ECV, measured at the time of birth 3. Attrition rate recorded as the number of participants who consent to participate who remain in the study until the end of follow-up at 4 months after birth 4. Long-term attrition rate recorded as the number of OptiBreech 1 participants who complete 1-year and 2-year follow-up surveys when invited | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/09/2023: (Primary outcomes for observational study) The following potential primary and secondary outcomes for a substantive trial will be feasibility-tested, and incidence rates will be used to inform power calculations for the substantive trial: 1. Admission to higher-level neonatal care, measured as a binary (yes/no) and continuous (number of days/nights) outcome from patients’ medical records at 28 days following birth 2. Mode of birth as a categorial measurement to include the following categories: vaginal breech birth, forceps breech, pre-labour caesarean section (CS), emergency CS, cephalic vaginal birth, cephalic forceps, cephalic ventous, from patients’ medical records on the day of birth 3. Composite neonatal-perinatal death or serious adverse morbidity including the following: 5-minute APGAR score 4 days, intubation/ventilation >24 hours, convulsions >24 hours, parenteral or tube feeding >24 hours; from patients’ medical notes at discharge 4. Composite maternal death or serious morbidity including the following: postpartum haemorrhage >1500 ml, obstetric anal sphincter injury, cervical laceration involving lower uterine segment, vertical uterine incision or serious extension to transverse uterine incision, bladder, ureter or bowel injury requiring repair, dilation and curettage for bleeding or retained placental tissue, manual removal of placenta, uterine rupture, hysterectomy, vulval or perineal haematoma requiring evacuation, wound dehiscence/breakdown, wound infection requiring prolonged hospital stay/readmission/antibiotics, sepsis, disseminated intravascular coagulation; from patients’ medical notes at discharge 5. Use of services following referral for breech care, including antenatal and postnatal appointments, total time spent admitted to hospital, number of ECVs, number of ultrasound scans, an | — |
Countries
England, United Kingdom
Outcome results
None listed