ISRCTN14521381
Active, not recruiting
未知
The OptiBreech Care Trial: a feasibility study for a pragmatic trial of care for women with a breech-presenting baby at term
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Breech pregnancy
- Sponsor
- King's College London
- Enrollment
- 273
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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)
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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