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Clinical Trials/ISRCTN14521381
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

King's College London0 sites273 target enrollmentOctober 18, 2021

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)

Registry
who.int
Start Date
October 18, 2021
End Date
August 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

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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