ROTATE RCT - Rotation of the fetal head at full cervical dilatation
Research type
Research Study
Full title
ROTATE Rotation of the fetal head at full cervical dilatation Randomised controlled trial of manual versus instrumental rotation of the fetal head in malposition at birth
IRAS ID
301912
Contact name
Dimitrios Siassakos
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN10193017
Duration of Study in the UK
2 years, 10 months, 2 days
Research summary
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. 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, straight after the birth and in the longer term. 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. A 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. We will also ask women about their birth experience and other important outcomes such as injury to the baby and impact on breastfeeding.
An embedded qualitative study will explore women's and healthcare professionals' views and experiences of all aspects of the trial.
REC name
London - Surrey Research Ethics Committee
REC reference
22/LO/0157
Date of REC Opinion
19 May 2022
REC opinion
Further Information Favourable Opinion