For Participants

The ROTATE study is investigating how best to get babies into a good position for a vaginal birth when problems arise at the end of labour. At this stage, most babies have rotated round in their mother/birthing person’s pelvis so that the back of their head (the occiput) is at the front of the pelvis. This position is most likely to result in a straightforward vaginal birth. But some babies end up in a position where the back of their head is against the woman/birthing person’s spine, or her left or right hip, making it more difficult to push the baby out and more likely she/they will have bad tears and/or more complex late second stage caesarean birth

Optimal birth position

Back-to-back position

In this situation an obstetrician (a doctor specialising in pregnancy and birth) will discuss the options and seek consent. When continuing with a vaginal birth, the obstetrician will help turn the baby so their head is in the best position for birth. There are currently two options that are already routinely used:

1. Using their hands to rotate the baby (manual rotation). The woman/birthing person may then be able to push the baby out without further assistance. If not, the obstetrician will use forceps or ventouse to help birth the baby.

2. Using forceps or ventouse to rotate the baby (instrumental rotation) and then to help birth the baby.

Currently, there is no conclusive evidence to say which method of rotating the baby’s head is best. Different doctors use different approaches, which is why we are doing the ROTATE study.

We want to find out which of these two methods is the best for both mothers/birthing people and their babies. We will be collecting information about the outcomes, such as tears and late caesarean sections. Obstetricians generally want to avoid carrying out caesareans in the second stage of labour as they are riskier to the woman/birthing person and baby than those that take place before labour starts or in early labour.

If your baby is not in the optimal position at the end of your labour and you decide to take part in the ROTATE study, details about you and your pregnancy will be put into a computer which will randomly choose one of the two methods of rotation. It is important to remember that both methods are already used by doctors, and neither is a new intervention. Your midwives and doctors will discuss with you the details of having an operative vaginal delivery, and the benefits and risks associated with this type of birth. Your needs and your baby’s needs always remain paramount. Should your doctor think it necessary to use a different method, or you have a preference, this will take precedence over the study. Before you leave hospital, you will be asked to complete a questionnaire about:

• Your experience of childbirth
• Feeding your baby

The answers that you provide will help health care staff and researchers get a fuller picture of your birth and postnatal experiences. You will be asked to complete these questionnaires again approximately 3 months after the birth to gain insight into the longer-term outcomes.

We currently don't know which method will provide the most benefit to you or your baby. It is possible that you and your baby may not gain any personal benefit. However, your participation may provide valuable information to help decide which method is best for women/birthing people and babies in the future.

It is important to remember that:

• Whether you take part or not is entirely your choice
• You can withdraw from the trial at any point without providing a reason
• Manual rotation and instrumental rotation (forceps or ventouse) are not new methods; we are investigating which method has the better outcomes

The design of the ROTATE study has been guided by a survey of women and birthing people with experience of operative vaginal birth. The Birth Trauma Association and the National Childbirth Trust also took part in developing the research. We have patient representatives on the Trial Management Group and a Trial Steering Committee that oversee the project. These representatives inform all aspects of the trial, including study design, materials, and procedures. A diverse Patient and Public Involvement Group, all of whom have had experience of assisted birth (vaginal or unplanned caesarean birth) have contributed to creating the information given to potential participants in the trial – including this webpage!

On operative vaginal birth: https://www.rcog.org.uk/for-the-public/browse-all-patient-information-leaflets/assisted-vaginal-birth-ventouse-orforceps

On perineal tears: https://www.rcog.org.uk/for-the-public/perineal-tears-and-episiotomies-in-childbirth/