Belinda Barnett

Background: Supporting intrapartum research through recruitment and intervention delivery and data collection can be challenging for clinical midwives. While there is a need for high-quality evidence of effective care during labour and birth, there are very few midwifery-led randomised controlled trials conducted during this period. Similarly, there is little research on the motivating factors and challenges for clinicians associated with intrapartum research. Aim: Our aim was to explore the experiences of midwives who participated in a placebo-controlled intrapartum trial. Methods: Midwives who had participated in a trial investigating the use of sterile water injections for managing abdominal labour pain were invited to participate. Semi-structured interviews were conducted via videoconferencing. Data were transcribed and analysed thematically. Results: Interviews were conducted with 11 midwives. Three themes were identified: (i) introducing a novel treatment for labour pain; (ii) the conflict of care and placebo and (iii) participating in a clinical trial. Conclusions: Participants described experiences ranging from the support for an experimental analgesia and expectations of effect, to reservations to participants potentially encountering the placebo treatment. At times the experiences were both positive and negative. Midwives often found the timing of providing trial information and obtaining informed consent challenging. Our findings highlight the challenges encountered by midwives when presenting trial information, establishing equipoise and the timing for these to occur during labour. Trial registration: The trial is registered at the Australian and New Zealand Clinical Trials Registry (Trial ID: ACTRN12621001036808). Registration date 5/08/2021.

Background: Up to 80% of women use some form of pharmacological analgesia during labour and birth. The side effects of pharmacological agents are often incompatible with the concurrent use of non-pharmacological pain relieving strategies, such as water immersion, ambulation and upright positioning, or may have negative effects on both the mother and fetus. Sterile water injections given into the skin of the lumbar region have been demonstrated to reduce back pain during labour. However, the injections given for back pain have no effect on abdominal contraction pain. The analgesic efficacy of sterile water injections for abdominal pain during childbirth is unknown. The injections cause an immediate, brief but significant pain that deters some women from using the procedure. This study aims to investigate the use of water injections given intradermally into the abdomen to relieve labour contraction pain. A vapocoolant spray will be applied to the skin immediately prior to the injections to reduce the injection pain. Methods: In this pragmatic, placebo controlled trial 154 low-risk women in labour at term with a labour pain score ≥ 60 on a 100 millimitre visual analogue scale (VAS) will be randomly allocated to receive either six injections of sterile water or a sodium chloride 0.9% solution as a placebo (0.1–.0.3 ml per injection). Three injections are given along the midline from the fundus to the supra-pubis and three laterally across the supra-pubis. The primary outcome will be the difference in VAS score 30 min post injection between groups. Secondary outcomes include VAS score of the injection pain on administration, VAS score of labour pain at 60 and 90 min, maternal and neonatal birth outcomes. Discussion: Access to effective pain relief during labour is fundamental to respectful and safe maternity care. Pharmacological analgesics should support rather than limit other non-pharmacological strategies. Sterile water injections have the potential to provide an alternative form of labour pain relief that is easy to administer in any labour and birth setting, and compatible with other non-pharmacological choices. Trial registration: ANZCTR (ACTRN12621001036808) Date submitted: 22/06/2021. Date registered: 05/08/2021. https://www.anzctr.org.au/