A trial of manual versus instrumental rotation of malpositioned babies at birth

ISRCTN	ISRCTN10193017
DOI	https://doi.org/10.1186/ISRCTN10193017
IRAS number	301912
Secondary identifying numbers	CPMS 52151, IRAS 301912

Submission date: 26/10/2022
Registration date: 24/11/2022
Last edited: 17/01/2025

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Making birth safer to prevent poor outcomes for mothers and their babies is an NHS priority. We know that births complicated by assisted birth can cause long-term health problems for women which can affect their physical and emotional health, relationships and careers. It can also have serious consequences for the baby. An assisted vaginal birth often happens when the baby is awkwardly positioned in the birth canal, for example when the baby's spine is resting against the mother's spine. This makes it much harder for the mother to push her baby out. Around 30,000 women per year in the UK (one in 25) are affected. In these cases doctors (obstetricians) and midwives will try to turn the baby into a better position, using either instruments (forceps or ventouse) or a manual technique with their hands. It is thought that the hand technique may result in less trauma for women and babies but we do not yet have the information needed to make a robust recommendation about this. This study will investigate which methods for rotating the baby at birth (hand or instrument) have the best outcomes for the mother and baby, both straight after the birth and in the longer term.

Who can participate?
Birthing people with a term baby who is positioned either ‘back-to-back’ or facing sideways at the pushing stage of labour, who will need a doctor to turn their baby’s head into the optimal position for birth.

What does the study involve?
A computer programme will randomly assign birthing people who consent to take part in the trial to one of two groups. One group will have manual rotation, and the second group will have instrumental rotation. The researchers will collect data to find out whether manual rotation is less likely to cause trauma to a woman's anus (back passage) and the perineum (skin between vagina and anus) without increasing the risk of caesarean birth. The researchers will also ask women about their birth experience and other important outcomes such as injury to the baby, impact on breastfeeding and their birth experience.

What are the possible benefits and risks of participating?
As we currently don’t know which method of rotating the baby’s head improves outcomes, there may not be any direct benefit to taking part in the trial. As both techniques are widely used as standard care, the risk of being randomised to one or the other is minimal. Through carrying out this trial, the researchers will be investigating the risks associated with each technique to better inform standard practice.

Where is the study run from?
The study is sponsored by University College London and is managed by the Birmingham Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
May 2022 to September 2025

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

Who is the main contact?
Laura Butler, rotate@trials.bham.ac.uk

Study website

Contact information

Dr Laura Butler
Scientific

Senior Trial Manager
Birmingham Clinical Trials Unit (BCTU)
College of Medical and Dental Sciences
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)7500007709
Email	rotate@trials.bham.ac.uk

Study information

Study design	Randomized; Interventional; Design type: Treatment, Management of Care, Other
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	42663_PIS_V2.0_21Mar22.pdf
Scientific title	Randomised controlled trial of manual versus instrumental rotation of the fetal head in malposition at birth
Study acronym	ROTATE
Study hypothesis	For women at full cervical dilatation with persistent malposition of the fetal head requiring a rotational assisted vaginal birth, does manual rotation of the fetal head compared to instrumental rotation with forceps or ventouse, reduce the incidence of 3rd- or 4th-degree perineal trauma (superiority hypothesis), without increasing the incidence of caesarean section birth (non-inferiority hypothesis)?
Ethics approval(s)	Approved 17/05/2022, London – Surrey Research Ethics Committee (no postal address given; +44 (0)2071048088; surrey.rec@hra.nhs.uk), ref: 22/LO/0157
Condition	Fetal head in malposition at birth
Intervention	Interventions (health technologies) being assessed: INTERVENTION – MANUAL ROTATION: Rotation of the fetal head by manual rotation - followed by direct forceps or direct ventouse or spontaneous effort. Instrument to be used for direct traction after the rotation at the choice of the obstetrician and recorded for further analysis. COMPARATOR – INSTRUMENTAL ROTATION: Rotation of the fetal head by rotational instrument (rotational forceps or rotational ventouse) at the choice of the obstetrician. Instrument to be used for direct traction after the rotation at the choice of the obstetrician – usually the same type of instrument (forceps or ventouse). The trial needs to be pragmatic if it is to be successfully delivered, hence the need for heterogeneous interventions in the control group, something which was acknowledged in the commissioning brief ‘Comparator: forceps or ventouse according to clinician expertise’; and the evidence synthesis by HTA "There was no significant difference in the risk ratio between [rotational] forceps & rotational ventouse in adverse maternal outcomes". In a national survey (with findings also supported by the REDEFINE national audit data), most of the obstetricians considered themselves competent in manual rotation and in only one of the instrumental techniques (either ventouse or rotational forceps). We consider the sample size sufficiently large for intended instrument to be balanced by trial arm, and so do not feel that it is necessary to add this as a stratification or minimisation factor for ventouse versus forceps, particularly as this would potentially increase the burden (and time spent) at the point of randomisation. INTERVIEWS - Qualitative study In the first instance, participants will be invited to participate in an interview via telephone/video conference (e.g. Zoom, Skype or WhatsApp). To ensure inclusivity, where participants are unable to participate virtually, the researchers may consider face-to-face interviews in the clinic where they were treated/work, at the University of Birmingham or University College London (if local to either), in the participant’s home or in an appropriate public space. The researchers will ensure that they are following appropriate COVID-related guidance if interviews are undertaken face-to-face. From experience, we anticipate that the vast majority will be done virtually. For women, the researchers will aim to conduct interviews within four to eight weeks of them being approached to participate (decliners) or being randomised (women who consent to randomisation). This will however remain flexible to accommodate the needs of the women. A discussion guide to facilitate the interviews will be developed informed by existing literature (for example the domains proposed in the Theoretical Framework for Acceptability of Healthcare Interventions [Sekhon], patient and public involvement, and discussions within the ROTATE team. Interviews will be conducted in a participant-focused manner allowing issues and perspectives important to participants to arise naturally [Clarke and Braun]. For women, interviews will explore their views and experiences of the treatment options (including perceived risks around instrumental intervention such as forceps), the recruitment approach, voluntariness, consent processes, randomisation, barriers and facilitators to participation, acceptability of randomisation, and experiences of care pre- and post-intervention. For healthcare professionals, interviews will explore their familiarity with, and exposure to, different types of interventions (manual, instrumental); training and confidence in the different interventions; views and experiences of recruitment, consent processes, randomisation, including perceived barriers and facilitators, equipoise, appropriateness and acceptability of the intervention, and perceptions of trial processes. Participants will be given the choice as to where an interview takes place (e.g. via phone, video call, or face-to-face). It is anticipated that a blended approach of face-to-face and virtual data collection will be used given the current COVID situation, social distancing and to maximise the facilitation of a large number of interviews/focus groups in a short period of time. There is also growing evidence that rapport can be readily established using remote techniques [Vogl]; and that the flexibility and adaptability afforded by technology minimises inconvenience and disruption to participants [Drabble; Sivell]. All participants will be asked to complete a brief demographic questionnaire prior to or and the end of the interview to facilitate purposive sampling and a description of the sample. INTERIM ANALYSES Interim analyses of safety and efficacy will be presented to the independent DMC/Trial Oversight Committee during the trial. This is likely to include the analysis of the primary and major secondary outcomes and full assessment of safety (SAEs) at least at annual intervals. Criteria for stopping or modifying the trial based on this information will be ratified by the DMC. Details of the agreed plan will be written into a DMC Charter and the Statistical Analysis Plan BIAS MINIMISATION Blinding: In this pragmatic study, given the nature of the interventions, it will not be possible to blind clinicians performing the intervention, or women, to the allocated randomised group. For key outcomes, including caesarean section as well as major neonatal trauma and morbidity, ascertainment is not prone to bias. Anal sphincter injury has to be repaired as soon as possible in the same (in most instances operating/theatre) room as the just delivered baby might have visible marks from the ventouse or forceps, which makes blinding to allocation unrealistic. Handling missing data: In the first instance, analysis will be completed on received data only with every effort made to follow-up participants even after protocol violation to minimise any potential for bias. To examine the possible impact of missing data on the results, and to make sure we are complying with the intention-to-treat principle, sensitivity analyses may be performed on the primary outcome measure that will include methods such as multiple imputation.
Intervention type	Procedure/Surgery
Primary outcome measure	Anal sphincter injury and Caesarean section (co-primary outcomes) measured from data collection on case report forms, including a checklist for the standardisation of perineal assessment, and documentation of the need for caesarean section. Completed immediately after birth.
Secondary outcome measures	1. Maternal and neonatal morbidity/mortality collected on a case report form within 48 hours of birth 2. Urinary incontinence measured using the International Consultation on Incontinence Questionnaire within 48 hours of birth and at 3 months after birth 3. Fecal incontinence measured using the Fecal Incontinence Quality of Life Questionnaire within 48 hours of birth and at 3 months after birth 4. Impact on infant feeding measured using the Breastfeeding Questionnaire within 48 hours and at 3 months after birth 5. Birth experience measured using the Childbirth Experience Questionnaire within 48 hours and at 3 months after birth 6. Birth trauma measured using the CITY Birth Trauma scale at 3 months after birth
Overall study start date	17/05/2022
Overall study end date	09/09/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	Female
Target number of participants	Planned Sample Size: 5200; UK Sample Size: 5200
Total final enrolment	321
Participant inclusion criteria	Main study: 1. ≥16 years of age at time of randomisation 2. Singleton pregnancy 3. ≥36 weeks’ gestation with cephalic presentation and persistent malposition of the fetal head occiput between 2 and 10 o’clock (diagnosed clinically or with ultrasound) requiring a rotational operative vaginal birth 4. Birth conducted or supervised by obstetricians signed off as competent in both manual and instrumental rotation (at least one of forceps/ventouse) Qualitative sub-study: 1. All women eligible for ROTATE and who are approached about the trial, irrespective if they agree to participate or not 2. All healthcare professionals caring for women in and involved in the delivery of ROTATE 3. Those able and willing to give informed consent
Participant exclusion criteria	Main study: 1. Women with contraindications for operative birth with either ventouse or forceps 2. Women with occiput between 11 and 1 o’clock (occipito-anterior). 3. Brow presentation 4. Intrauterine fetal death Qualitative sub-study: 1. Participants who would be unable to take part in an interview due to language barriers (interviews will be undertaken in English)
Recruitment start date	11/09/2022
Recruitment end date	31/10/2024

Locations

Countries of recruitment

England
Northern Ireland
Scotland
United Kingdom

Study participating centres

University College London Hospitals

Elizabeth Garrett Anderson Wing
25 Grafton Way
London
WC1E 6DB
United Kingdom

Leeds General Infirmary

Great George Street
Leeds
LS1 3EX
United Kingdom

Sunderland Royal Hospital

Kayll Road
Sunderland
SR4 7TP
United Kingdom

Liverpool Women's Hospital

Crown Street
Liverpool
L8 7SS
United Kingdom

University Hospital Coventry

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Rosie Maternity Hospital

Robinson Way
Cambridge
CB2 0SW
United Kingdom

St Thomas' Hospital

Westminster Bridge Road
London
SE1 7EH
United Kingdom

James Cook University Hospital

Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Queens Medical Centre

6-7 Queen Street
Barnstaple
EX32 8HY
United Kingdom

Queens Medical Centre

Derby Road
Nottingham
NG7 2UH
United Kingdom

Birmingham Womens Hospital

Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom

The Whittington Hospital

Highgate Hill
London
N19 5NF
United Kingdom

St Michaels Hospital

St. Michaels Road
Warwick
CV34 5QW
United Kingdom

Royal Maternity Hospital Belfast

274 Grosvenor Rd
Belfast
BT12 6BA
United Kingdom

St Georges Hospital

Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Newham General Hospital

Glen Road
London
E13 8SL
United Kingdom

Whipps Cross Hospital

Whipps Cross Road
London
E11 1NR
United Kingdom

Royal London Hospital

Whitechapel
London
E1 1BB
United Kingdom

Warwick Hospital

Lakin Road
Warwick
CV34 5BW
United Kingdom

Southmead Hospital

Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom

Queen Charlotte's Hospital

Du Cane Road
London
W12 0HS
United Kingdom

Queen Elizabeth University Hospital

1345 Govan Road
Glasgow
G51 4TF
United Kingdom

The Princess Royal Maternity Unit

16 Alexandra Parade
Glasgow
G31 2ER
United Kingdom

Carlisle City Maternity Hospital

Fusehill Street
Carlisle
CA1 2HF
United Kingdom

St James's University Hospital

Beckett Street
Leeds
LS9 7TF
United Kingdom

Leicester General Hospital

Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Leicester Royal Infirmary

Infirmary Square
Leicester
LE1 5WW
United Kingdom

The Royal Victoria Infirmary

Queen Victoria Road
Newcastle upon Tyne
TS1 4LP
United Kingdom

University Hospital of Wales

Heath Park
Cardiff
CF14 4XW
United Kingdom

Peterborough City Hospital

Edith Cavell Campus
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom

University Hospital Lewisham

Lewisham High Street
London
SE13 6LH
United Kingdom

Northwick Park Hospital

Watford Road
Harrow
HA1 3UJ
United Kingdom

Colchester General Hospital

Colchester District General Hosp.
Charter Way
Turner Road
Colchester
CO4 5JL
United Kingdom

Royal Berkshire Hospital

Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom

Royal United Hospital

Combe Park
Bath
BA1 3NG
United Kingdom

Bradford Royal Infirmary

Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Ninewells Hospital

Ninewells Avenue
Dundee
DD1 9SY
United Kingdom

Frimley Park Hospital

Frimley Park Scanning Centre
Portsmouth Road
Frimley
Camberley
GU16 7UJ
United Kingdom

Royal Free Hospital

Pond Street
London
NW3 2QG
United Kingdom

Norfolk & Norwich University Hospital

Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom

Plymouth Hospital

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Aberdeen Maternity Hospital

Foresterhill
Aberdeen
AB25 2ZL
United Kingdom

William Harvey Hospital

Kennington Road
Willesborough
Ashford
TN24 0LZ
United Kingdom

Victoria Hospital Kirkaldy

Hayfield Rd
Kirkcaldy
KY2 5AH
United Kingdom

North Middlesex Hospital

Sterling Way
London
N18 1QX
United Kingdom

University Hospital of North Tees

Hardwick Road
Stockton-on-tees
TS19 8PE
United Kingdom

Chelsea and Westminster Hospital

369 Fulham Road
London
SW10 9NH
United Kingdom

Northumbria Specialist Emergency Care Hospital

Northumbria Way
Cramlington
NE23 6NZ
United Kingdom

Heartlands Hospital

Bordesley Green East
Bordesley Green
Birmingham
B9 5ST
United Kingdom

Good Hope Hospital

Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom

Sponsor information

University College London
Hospital/treatment centre

Gower Street
London
WC1E 6BT
England
United Kingdom

Phone	+44 (0)20 3447 5696
Email	pushpsen.joshi1@nhs.net
Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR127818

No information available

Results and Publications

Intention to publish date	01/05/2026
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The researchers will create a dedicated website to communicate the progress and findings. Their patient/public partners (National Childbirth Trust [NCT], BTA, Bliss, and the Senior PPI Board) as well as other charities and parent support groups that we work with closely will disseminate the results to parents through their networks. The study team, supported by academic and patient/public partners will actively use their highly visible social media profiles (Twitter, Facebook, Mumsnet, Instagram) to disseminate approved short vignettes, graphics, and videos of the study findings to the widest possible audience. The researchers will work with the NIHR research networks, Academic Health Science Networks and Applied Research Collaborations. Their findings will inform evidence to support the professional evaluation of guidance on operative birth via the Royal College of Obstetricians and Gynaecologists (RCOG) and NICE. The researchers will prepare a slide set for participating professionals to disseminate findings. They plan to present ROTATE findings to NHS England Specialist Commissioning through the Women and Children’s Programme of Care so that findings are considered within their parallel Quality and Safety Reviews, as part of the ongoing quality improvement programme. The researchers are working closely with NHS England on optimising consent in maternity and particularly operative birth. The researchers expect the results to be published in high-impact factor peer-reviewed journals including The Lancet, British Medical Journal and An International Journal of Obstetrics and Gynaecology. They will also submit the study protocol to a relevant journal (e.g. Trials). The National Institute for Health Research Library will promote key messages and reports. They plan to publish the findings of ROTATE around May 2026.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from the ROTATE trial team: rotate@trials.bham.ac.uk. Requests for data generated during this study will be considered by BCTU. Data will typically be available within 6 months after the primary publication unless it is not possible to share the data (for example: the trial results are to be used as part of a regulatory submission, the release of the data is subject to the approval of a third party who withholds their consent, or BCTU is not the controller of the data). Only scientifically sound proposals from appropriately qualified Research Groups will be considered for data sharing. The request will be reviewed by the BCTU Data Sharing Committee in discussion with the Chief Investigator and, where appropriate (or in absence of the Chief Investigator) any of the following: the Trial Sponsor, the relevant Trial Management Group (TMG), and independent Trial Steering Committee (TSC). A formal Data Sharing Agreement (DSA) may be required between respective organisations once the release of the data is approved and before data can be released. Data will be fully de-identified (anonymised) unless the DSA covers the transfer of patient-identifiable information, provided consent has been obtained for this transfer. Any data transfer will use a secure and encrypted method.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 2.0	21/03/2022	23/11/2022	No	Yes
HRA research summary			28/06/2023	No	No
Protocol file	version 4.0	18/11/2022	12/12/2023	No	No
Statistical Analysis Plan	version 1.0	24/02/2023	12/12/2023	No	No

Additional files

42663_PIS_V2.0_21Mar22.pdf
42663 ROTATE Protocol V4.0 18Nov2022 final.pdf
42663 ROTATE Statistical Analysis Plan v1.0_24Feb23.pdf

Editorial Notes

17/01/2025: Total final enrolment added.
12/12/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
26/10/2022: Trial's existence confirmed by the NIHR.