Background
Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisting the woman during the second stage of labour.
Methods/design
In this multicentre randomised controlled trial, 2946 women will be randomised to be assisted by one or two midwives during the second stage of labour. Women age 18–47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward. Five maternity wards comprising 19,500 births/year in different parts of Sweden will participate in this study. The sample size is powered to demonstrate a 50% reduction (from 4.1–2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree). Secondary outcomes will include maternal and neonatal outcomes, women’s experiences, midwives’ experiences of the intervention, incontinence, and pelvic floor symptoms. The primary analysis is intention to treat. Questionnaires will be sent to the women at 1 month and 1 year after the birth to assess women’s experiences, pain, incontinence, pelvic floor symptoms, sexual function, and mental health.
Discussion
It is important for care during labour and birth to be evidence based. There is a strong desire among midwives to reduce the risk of severe perineal trauma. This may lead to new strategies and practices being implemented into practice without scientific evidence. The intervention might have negative side effects or unintended consequences. On the other hand, there is a possibility of the intervention improving care for women.
Trial registration {2a}
ClinicalTrials.gov NCT03770962. Registered on 10 December 2018
for the fetal scalp sampling test. In this large study of nearly 1400 patients, there were no statistically significant differences in the fetal outcomes; however, every measure of fetal acidemia or low Apgar scores was worse in the pH group with P values ranging from 0.07 to 0.11. There was an increased risk of cesarean delivery, 16.5% versus 12.4%, in the lactate group.This is interesting, it would be easy to suggest that fetal scalp lactate increases the risk of cesarean delivery without benefit, but I think that would lead to a potential type II error. What is needed are larger studies of this question and potentially meta-analyses. The truth might be that lactate has a slightly higher sensitivity for fetal compromise than fetal pH, but with some small loss in specificity.But for those of us practicing in the United States, such studies are moot. As the field of fetal assessment in labor continues to progress, we are being left behind. It is going to take some real effort and support of national organizations to reintroduce fetal scalp sampling, but given both our unacceptably high rate of cesarean delivery and lack of progress with fetal heart rate monitoring, it seems like we should do just that.-ABC)
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