Decreasing rates of assisted vaginal birth have been paralleled with increasing rates of cesarean deliveries over the last 40 years. The OdonAssist is a novel device for assisted vaginal birth. ...Iterative changes to clinical parameters, device design, and technique have been made to improve device efficacy and usability.
This study aimed to determine if the feasibility, safety, and efficacy of the OdonAssist device were sufficient to justify conducting a future randomized controlled trial.
An open-label nonrandomized study of 104 participants having a clinically indicated assisted vaginal birth using the OdonAssist was undertaken at Southmead Hospital, Bristol, United Kingdom. Data were also collected from participants who consented to participate in the study but for whom trained OdonAssist operators were not available, providing a nested cohort. The primary clinical outcome was the proportion of births successfully expedited with the OdonAssist. Secondary outcomes included clinical, patient-reported, operator-reported, device and health care utilization. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. Given that the number of successful OdonAssist births was ≥61 out of 104, the hypothesis of a poor rate of 50% was rejected in favor of a good rate of ≥65%.
Between August 2019 and June 2021, 941 (64%) of the 1471 approached, eligible participants consented to participate. Of these, 104 received the OdonAssist intervention. Birth was assisted in all cephalic vertex fetal positions, at all stations ≥1 cm below the ischial spines (with or without regional analgesia). The OdonAssist was effective in 69 of the 104 (66%) cases, consistent with the hypothesis of a good efficacy rate. There were no serious device-related maternal or neonatal adverse reactions, and there were no serious adverse device effects. Only 4% of neonatal soft tissue bruising in the successful OdonAssist group was considered device-related, as opposed to 20% and 23% in the unsuccessful OdonAssist group and the nested cohort, respectively. Participants reported high birth perception scores. All practitioners found the device use to be straightforward.
Recruitment to an interventional study of a new device for assisted vaginal birth is feasible; 64% of eligible participants were willing to participate. The success rate of the OdonAssist was comparable to that of the Kiwi OmniCup when introduced in the same unit in 2002, meeting the threshold for a randomized controlled trial to compare the OdonAssist with current standard practice. There were no disadvantages of study participation in terms of maternal and neonatal outcomes. There were potential advantages of using the OdonAssist, particularly reduced neonatal soft tissue injury. The same application technique is used for all fetal positions, with all operators deeming the device straightforward to use. This study provides important data to inform future study design.
The incretin hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), may be responsible for up to 70% of postprandial insulin secretion. In type 2 diabetes ...(2DM), the incretin effect is severely reduced. Secretion of GIP is normal, but its effect on insulin is lost. GLP-1 secretion may be impaired, but its actions may restore insulin secretion to near normal levels. Substitution therapy with GLP-1 might therefore be possible. GLP-1 actions include potentiation of glucose-induced insulin secretion, up-regulation of insulin and other β-cell genes, stimulation of β-cell proliferation and neogenesis and inhibition of β-cell apoptosis, inhibition of glucagon secretion, inhibition of gastric emptying, and inhibition of appetite and food intake. It may also have cardioprotective and neuroprotective actions. These actions make GLP-1 particularly attractive as a therapeutic agent for 2DM, but GLP-1 is rapidly destroyed in the body by the enzyme, dipeptidyl peptidase IV (DPP-IV). Clinical strategies therefore include (i) the development of metabolically stable activators of the GLP-1 receptor and (ii) inhibition of DPP-IV. Orally active DPP-IV inhibitors are currently undergoing clinical trials, and recent clinical studies have provided long-term proof of concept. Metabolically stable analogs/activators include the structurally related lizard peptide, exendin-4, or analogs thereof, as well as GLP-1-derived molecules that bind to albumin and thereby assume the pharmacokinetics of albumin. These molecules are effective in animal experimental models of 2DM and have been employed successfully in clinical studies of up to 82 weeks’ duration, and exendin-4 has just been approved for add-on therapy of 2DM.
