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
- 29/05/2025
- 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 July 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
Contact information
Dr Laura Butler
Scientific
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 |
|---|---|
| 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 (Nottingham Centre, The Old Chapel Royal, Standard Place, Nottingham, NG1 6FS, United Kingdom; +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 | 31/07/2025 |
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
25 Grafton Way
London
WC1E 6DB
United Kingdom
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Leeds
LS1 3EX
United Kingdom
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
Liverpool
L8 7SS
United Kingdom
University Hospital Coventry
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Coventry
CV2 2DX
United Kingdom
Rosie Maternity Hospital
Robinson Way
Cambridge
CB2 0SW
United Kingdom
Cambridge
CB2 0SW
United Kingdom
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
SE1 7EH
United Kingdom
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Nottingham University Hospitals NHS Trust - City Campus
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
The Whittington Hospital
Highgate Hill
London
N19 5NF
United Kingdom
London
N19 5NF
United Kingdom
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
Bath
BA1 3NG
United Kingdom
University Hospital of North Tees
Hardwick Road
Stockton-on-tees
TS19 8PE
United Kingdom
Stockton-on-tees
TS19 8PE
United Kingdom
Royal Infirmary of Edinburgh at Little France
51 Little France Crescent
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Sponsor information
University College London
Hospital/treatment centre
Hospital/treatment centre
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0)20 3447 5696 |
|---|---|
| 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 | 31/07/2025 |
|---|---|
| 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
Editorial Notes
29/05/2025: The following changes were made to the trial record:
1. The overall end date was changed from 09/09/2025 to 31/07/2025.
2. The study participating centres were updated.
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.
