ROTATE trial 

• Pragmatic, multi-centre, 2-arm parallel group, open-label, randomised controlled trial.
• Randomisation to either manual or instrumental rotation at the level of the individual using a 1:1 allocation ratio, minimised by centre and baby’s position (occipito–transverse or posterior).

The first 9 months of the ROTATE study will consist of an internal pilot with embedded qualitative process evaluation in approximately 12 geographically diverse units with clear progression criteria to the main trial.

Primary objective

• To evaluate if manual rotation compared with instrumental rotation of babies with persistent head malposition at full cervical dilatation reduces the risk of severe maternal perineal trauma, without substantially increasing the risk of caesarean section.

Secondary objectives

• To evaluate the success of vaginal delivery with the use of the first method
• To evaluate whether there are differences between the two rotational techniques in important additional clinical outcomes for mothers and babies, including a key secondary outcome: severe neonatal trauma as safety signal
• To establish a randomised cohort of women who have experienced malposition of the fetal head for future long-term follow-up of mothers (at two, five and ten years) and babies (neuro-developmental outcomes at two years.

NHS consultant-led maternity units in the UK

Women at full cervical dilatation (second stage of labour) with persistent malposition of the fetal head. A total sample of 5,200 women from approximately 40 sites.

Manual rotation and instrumental rotation (either forceps or ventouse depending on practitioner preference) allocated on a 1:1 ratio.

Primary: Third/fourth degree tear of maternal anal sphincter (superiority co-primary outcome). Caesarean section (non-inferiority co-primary outcome).

Secondary: Successful vaginal delivery with first instrument, neonatal morbidity, maternal childbirth experience, incontinence, breastfeeding and post-traumatic stress disorder (PTSD) symptoms.

Qualitative Process Evaluation: Explore experiences of trial processes for women and healthcare professionals.