The OptiBreech Care Trial: a small randomised trial to determine whether a large trial is possible for women with a breech-presenting baby at term

ISRCTN	ISRCTN14521381
DOI	https://doi.org/10.1186/ISRCTN14521381
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	303028
Protocol serial number	IRAS 303028, CPMS 50898
Sponsor	King's College London
Funder	National Institute for Health Research

Submission date: 01/07/2021
Registration date: 18/10/2021
Last edited: 04/01/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Current Plain English summary as of 07/09/2023:
Background and study aims
This study aims to determine whether it is possible to compare care for vaginal breech birth from a skilled and experienced specialist team. This care pathway is called ‘OptiBreech care’.

Who can participate?
Women with otherwise healthy pregnancies, who are pregnant with a breech-presenting baby at term (>37 weeks)

What does the study involve?
Women participating in the nested randomised controlled trial (now closed) will be allocated by chance (‘randomised’) to either OptiBreech care or ECV. They can choose to accept the intervention or decline it, as in standard maternity care. Non-randomised women participating in the prospective observational study will receive OptiBreech collaborative care for a planned vaginal breech birth. The maternity care professionals who provide care will record information about how much and what kind of care women have in pregnancy and during birth. This information will be entered into a database and kept separate from any details that could link it to an individual person, such as name and dates of birth. The study team will send participants follow-up surveys at 1 month, 3-4 months, 1 year and 2 years following the birth.

What are the possible benefits and risks of participating?
Previous studies have shown participation in clinical trials improves outcomes in women’s health compared to non-participation, regardless of whether they are allocated to the new treatment. Specialist care for vaginal breech births is available in very few hospitals. Keeping a record of appointments and completing follow-up surveys may be time-consuming. Also, vaginal breech birth where there is no control for the skill and experience of attendants is not as safe as head-first birth. OptiBreech care may or may not change this.

Where is the study run from?
King’s College London (UK)

When is the study starting and how long is it expected to run from?
November 2018 to August 2024

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Shawn Walker
Shawn.Walker@kcl.ac.uk

Previous Plain English summary:
Background and study aims
This study aims to determine whether it is possible to compare care for vaginal breech birth from a skilled and experienced specialist team with trying turning the baby head-down, for women whose baby is breech (bottom-down) at the end of pregnancy. These two care pathways are called ‘OptiBreech care’ and ‘external cephalic version (ECV)’.

Who can participate?
Women with otherwise healthy pregnancies, who are planning a vaginal birth prior to finding out their baby is breech, and have not yet had an attempt at turning the baby (ECV)

What does the study involve?
Participating women will be allocated by chance (‘randomised’) to either OptiBreech care or ECV. They can choose to accept the intervention or decline it, as in standard maternity care. The maternity care professionals who provide care will record information about how much and what kind of care women have in pregnancy and during birth. This information will be entered into a database and kept separate from any details that could link it to an individual person, such as name and dates of birth. The study team will send participants follow-up surveys at 1 month, 3-4 months, 1 year and 2 years following the birth.

What are the possible benefits and risks of participating?
Previous studies have shown participation in clinical trials improves outcomes in women’s health compared to non-participation, regardless of whether they are allocated to the new treatment. Specialist care for vaginal breech births is available in very few hospitals. Keeping a record of appointments and completing follow-up surveys may be time-consuming. Also, vaginal breech birth where there is no control for the skill and experience of attendants is not as safe as head-first birth. OptiBreech care may or may not change this.

Where is the study run from?
King’s College London (UK)

When is the study starting and how long is it expected to run from?
November 2018 to August 2023

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Shawn Walker
Shawn.Walker@kcl.ac.uk

Contact information

Dr Shawn Walker
Scientific

King's College London
Women and Children's Health Department
10th Floor, North Wing, St Thomas' Hospital
London
SE1 7EH
United Kingdom

ORCID ID	0000-0003-3658-8988
Phone	+44 (0)7947819122
Email	Shawn.Walker@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Two-arm pilot randomized controlled trial, nested within a prospective observational cohort study
Secondary study design	Prospective observational cohort study
Study type	Participant information sheet
Scientific title	The OptiBreech Care Trial: a feasibility study for a pragmatic trial of care for women with a breech-presenting baby at term
Study acronym	OptiBreech Care
Study objectives	Current study hypothesis as of 07/09/2023: It is feasible to conduct a pragmatic trial comparing OptiBreech care with standard care for women with a breech pregnancy at term Previous study hypothesis: It is feasible to conduct a pragmatic randomised controlled trial comparing OptiBreech care with external cephalic version for women with a breech pregnancy at term
Ethics approval(s)	Approved 23/11/2021, West London & GTAC Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 (0)207 1048098; westlondon.rec@hra.nhs.uk), ref: 21/LO/0808
Health condition(s) or problem(s) studied	Breech pregnancy
Intervention	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 randomised to ‘standard care,’ prohibiting comparison in 1:1 randomisation): The randomisation schedule will be computer-generated using MedSciNet software. Allocation will be automatic during the enrolment process on the database and revealed to the person who is taking consent and enrolling the participant in the study. Minimalisation factors will include site, parity (0 vs 1 or more previous births), type of breech presentation (extended/frank vs any other), and gestation at enrolment (<36, 36-38+6, 39+ weeks). Allocation between arms will be equal. The enrolment log will be completed automatically through the database. Participating women will be randomised to either OptiBreech care (specialist care for vaginal breech birth from professionals who meet minimum proficiency criteria), or external cephalic version (ECV) and offer caesarean if unsuccessful. They can choose to accept the intervention or decline it, as in standard maternity care. The maternity care professionals who provide care will record information about how much and what kind of care women have during pregnancy and during birth. This information will be entered into a database and kept separate from any details that could link it to an individual person, such as name and date of birth. The study team will send participants follow-up surveys at 1 month, 3-4 months, 1 year and 2 years following the birth. Prospective cohort: Women requesting support for vaginal breech birth will receive OptiBreech collaborative care. That is, professionals with advanced training in physiological breech birth attend VBBs whenever possible. The service is coordinated by a Breech Specialist Midwife with support from a Breech Lead Obstetrician. A small, experienced team provides continuity for women and professionals; their role is to train and support the wider team. Previous interventions: The randomisation schedule will be computer-generated using MedSciNet software. Allocation will be automatic during the enrolment process on the database and revealed to the person who is taking consent and enrolling the participant onto the study. Minimalisation factors will include site, parity (0 vs 1 or more previous births), type of breech presentation (extended/frank vs any other), and gestation at enrolment (<36, 36-38+6, 39+ weeks). Allocation between arms will be equal. The enrolment log will be completed automatically through the database. Participating women will be randomised to either OptiBreech care (specialist care for vaginal breech birth from professionals who meet minimum proficiency criteria), or external cephalic version (ECV) and offer caesarean if unsuccessful. They can choose to accept the intervention or decline it, as in standard maternity care. The maternity care professionals who provide care will record information about how much and what kind of care women have in pregnancy and during birth. This information will be entered into a database and kept separate from any details that could link it to an individual person, such as name and dates of birth. The study team will send participants follow-up surveys at 1 month, 3-4 months, 1 year and 2 years following the birth.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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 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
Key secondary outcome measure(s)	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, peripheral nerve injury present at discharge from hospital, skull fracture, spinal cord injury, admission to NICU >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, and professionals present at birth; measured at 28 days following birth 6. Satisfaction with care measured using previously validated survey questions with a 5-point Likert scale, from patients’ medical notes at 28 days post-birth 7. Experience of childbirth measured using the Childbirth Experience Questionnaire at 1-month post-birth 8. Health-related quality of life measured using the PROMIS-10 survey at 1 month, 3-4 months, 1 year and 2 years following the birth Previous secondary outcome measures: 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 <7, peripheral nerve injury present at discharge from hospital, skull fracture, spinal cord injury, admission to NICU >4 days, intubation/ventilation >24 hours, convulsions >24 hours, parenteral or tube feeding >24 hours; from patients’ medical notes at 28 days following birth 4. Composite maternal death or serious morbidity including the following: postpartum haemorrhage >1000 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 28 days following birth 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, and professionals present at birth; measured at 28 days following birth 6. Satisfaction with care measured using previously validated survey questions with a 5-point Likert scale, from patients’ medical notes at 28 days post-birth 7. Experience of childbirth measured using the Childbirth Experience Questionnaire at 1-month post-birth 8. Health-related quality of life measured using the PROMIS-10 survey at 1 month, 3-4 months, 1 year and 2 years following the birth 9. Infant’s development measured using the appropriate Ages and Stages Questionnaires at 3-4 months, 1 year and 2 years following the birth
Completion date	31/08/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	273
Key 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
Key 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
Date of first enrolment	07/01/2022
Date of final enrolment	31/01/2024

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Chelsea and Westminster Hospital

369 Fulham Rd
London
SW10 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
IPD sharing plan	Current IPD sharing plan as of 07/09/2023: Anonymised raw data will be made available as supplementary material in open-access publications, in accordance with the NIHR publication guidance, and stored in a repository for longer-term availability, in accordance with WHO and ICMJE guidance. Following the end of the study, anonymised data will be archived on the university’s secure Sharepoint site. This will be accessible only to the research team. Anonymised data will be stored in a Microsoft Excel Spreadsheet. All person-identifiable information will be removed or altered. For example, all dates will be converted to time-to-event intervals from the estimated date of birth, or actual data of birth for follow-up surveys. Prospective consent is obtained to use anonymised data in future studies, subject to appropriate ethics and data access approvals. Apply for access via the Chief Investigator Dr Shawn Walker (Shawn.Walker@kcl.ac.uk). All available data is available on Figshare: https://figshare.com/collections/OptiBreech_Care_IRAS_303028/6386370. Current IPD sharing plan: Anonymised raw data will be made available as supplementary material in open-access publications, in accordance with the NIHR publication guidance, and stored in a repository for longer-term availability, in accordance with WHO and ICMJE guidance. Following the end of the study, anonymised data will be archived on the university’s secure Sharepoint site. This will be accessible only to the research team. Anonymised data will be stored in a Microsoft Excel Spreadsheet. All person-identifiable information will be removed or altered. For example, all dates will be converted to time-to-event intervals from the estimated date of birth, or actual data of birth for follow-up surveys. Prospective consent is obtained to use anonymised data in future studies, subject to appropriate ethics and data access approvals. Apply for access via the Chief Investigator Dr Shawn Walker (Shawn.Walker@kcl.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Pilot	15/11/2023	16/11/2023	Yes	No
Dataset	Pilot trial data	15/01/2023	07/09/2023	No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Preprint results		23/11/2023	04/01/2024	No	No
Protocol file	version 1.1	01/11/2021	04/04/2022	No	No
Protocol file	version 1.2	20/06/2022	05/09/2023	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN14521381_Protocol_v1.1_01Nov21.pdf: Protocol file
ISRCTN14521381_PROTOCOL_V1.2_20Jun22.pdf: Protocol file

Editorial Notes

04/01/2024: Publication reference added.
16/11/2023: Publication reference added.
07/09/2023: The following changes have been made:
1. The plain English summary was changed.
2. The study hypothesis was changed.
3. The study design was changed from "Two-arm randomized controlled trial" to "Two-arm pilot randomized controlled trial, nested within a prospective observational cohort study".
4. The secondary study design was changed from "Randomised controlled trial" to "Prospective observational cohort study".
5. A link to patient information material has been added.
6. The interventions were changed.
7. The primary outcome measures were changed.
8. The secondary outcome measures were changed.
9. The overall study end date was changed from 31/08/2023 to 31/08/2024
10. The participant inclusion criteria were changed.
11. The target number of participants was changed from "104" to "104 (pilot trial); 206 (non-randomised); 273 (overall)".
12. The recruitment end date was changed from 07/07/2022 to 31/01/2024.
13. The intention to publish date was changed from 01/10/2023 to 01/10/2024.
14. The individual participant data (IPD) sharing plan was changed.
15. Dataset added.
05/09/2023: Protocol uploaded.
04/04/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2022 to 07/07/2022.
2. The protocol (not peer reviewed) has been uploaded as an additional file.
14/12/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2021 to 07/01/2022.
2. Ethics approval details added.
01/11/2021: The IRAS and CPMS numbers were added.
06/07/2021: Trial's existence confirmed by the NIHR.