Title: ROTATE_x000D_ Rotation of the fetal head at full cervical dilatation
Funder: Department of Health and Social Care

Abstract: 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. _x000D_ _x000D_ 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 research project will investigate which methods for rotating the baby at birth (hand or instrument) have the best outcomes for mother and baby, both straight after the birth and in the longer term._x000D_ _x000D_ We plan to ask and recruit 5,200 women to take part in the trial. We won’t know who is eligible to take part until they are in the advanced stages of labour. We have discussed this with groups of parents and have taken their advice that we need to produce easy to understand information about the trial that will be made available to women during their pregnancy. The information will include leaflets, posters and social media posts. The trial will initially run in six hospitals for nine months, then roll out to a total of 40 hospitals. This should mean we are able to recruit enough women, and collect enough data to have a clear picture of the impact of these techniques for assisted birth._x000D_ _x000D_ A computer programme will randomly assign women in labour who consent to take part in the trial to one of two groups. One group of women will have manual rotation, and the second group will have instrumental rotation._x000D_ _x000D_ We 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. This is because caesarean section in the later stages of labour can be risky and result in considerable trauma to the mother and baby, as well as bad outcomes in future pregnancies including very preterm birth._x000D_ We will also ask women about their birth experience and other important outcomes such as injury to the baby and impact on breastfeeding. We developed a list of outcomes after talking to parents, parenting organisations and charities, obstetricians and midwives. _x000D_ _x000D_ Two charities that support parents, NCT and the Birth Trauma Association, are part of our research team. They will help ensure our trial is parent focussed and that the results are widely shared with parents, midwives and obstetricians, and other key people. We will create a dedicated website to communicate the progress of the trial and our findings. This will include information sheets, simple summaries, and infographics for parents and the public. The study results will be published in a leading medical journal. This research will also be used to improve ROBuST, a compulsory training programmed for doctors run by the Royal College of Obstetricians and Gynaecologists

Lay abstract: RESEARCH QUESTION _x000D_ 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 risk of severe maternal perineal trauma without substantially increasing the risk of caesarean section?_x000D_ _x000D_ BACKGROUND _x000D_ Persistent malposition of the fetal head at full cervical dilatation affects 4% of women giving birth vaginally (30,000 per year in the UK) and is a strong predictor for poor maternal and neonatal outcomes such as anal sphincter injury (RR 1.25) and caesarean section (RR 4.4), with the raised risk of pre-term births in subsequent pregnancies (birth <32 weeks RR 2.12). Current strategies to manage malposition include manual rotation followed by direct forceps and instrumental rotational birth (either rotational ventouse or rotational forceps). There is no consensus as to which is the safest and most effective method of expediting birth. _x000D_ _x000D_ AIMS AND OBJECTIVES _x000D_ The ROTATE study will determine if manual rotation is superior to instrumental rotation for women and their babies with malposition in the second stage. This will enable national guidelines and training to identify and facilitate the mode of birth that promotes outcomes that are important to women and their families. _x000D_ _x000D_ METHODS _x000D_ Pragmatic, multicentre, 2-arm parallel group, open-label randomised controlled trial with an internal pilot. Manual rotation and instrumental rotation (either forceps or ventouse depending on practitioner preference) allocated in a 1:1 ratio. Co-primary outcomes are severe maternal perineal trauma (superiority hypothesis) and caesarean section (non-inferiority hypothesis). Secondary outcomes include severe neonatal trauma as safety signal, and reflect other key maternal and neonatal clinical outcomes as well as quality of experience and of life. A total sample of 5,200 women from approximately 40 sites will be recruited to allow detection of a reduction in perineal trauma from 6% to 4% with 90% power, and a non-inferiority margin of 3% assuming a 12% control group rate for the caesarean section co-primary outcome. This allows for a 4% loss to follow-up rate. _x000D_ _x000D_ TIMELINES FOR DELIVERY _x000D_ From approval, 48 months until completion of data analysis. Of this, six months of set-up, 30 months of data collection (see detailed study plan) and eight months of close-down and data analysis. _x000D_ _x000D_ ANTICIPATED IMPACT AND DISSEMINATION _x000D_ Clear findings that either manual or instrumental rotation is safer and/or more effective will guide care and training in the future, including informed consent discussions. Once disseminated through open-access peer-reviewed medical journals, national and international conferences and direct presentations to decision makers within NICE and the RCOG, the results will be integrated into national guidance and compulsory obstetric training (ROBuST). The ROTATE study team is uniquely placed to ensure rapid and meaningful adoption – the Chief Investigator is the RCOG ROBuST Convenor, a co-investigator and PI is co-author of the current RCOG Operative Vaginal Birth guidance, and multiple co-applicants are high-level influencers in Operative Vaginal Birth practice within the UK. In addition to a dedicated study website, our patient/public partners will help prepare and disseminate lay summaries including for social media.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH