A Ke Su Di Qu

Nausea and vomiting during pregnancy (NVP) is a common and challenging problem in the first trimester that significantly affects the quality of life of pregnant women. Current treatments are limited due to concerns about drug safety for the embryo and discomfort associated with traditional acupuncture methods. This study evaluates the clinical efficacy and safety of thumbtack needle (TN), a type of shallow puncture intradermal needle, as a treatment for moderate to severe NVP. The trial is a multi-center, large-sample, randomized, controlled, and blinded clinical study designed to provide high-quality evidence on TN's effects on nausea, vomiting, quality of life, anxiety, depression, and various pregnancy and neonatal outcomes. Participants receive either real thumbtack needle treatment or a sham thumbtack needle that looks similar but lacks the needle body and stimulation. The TN is applied to specific acupoints and retained for 3 days before removal and reapplication by a doctor, with a total of five treatments over 15 days. The sham treatment group follows the same schedule and procedures without the needle effect. This approach aims to compare the effects of continuous and stable stimulation by TN against a placebo-like control. During the study, participants are assessed for changes in nausea and vomiting using the Pregnancy Unique Quantification of Emesis (PUQE) scale from baseline to day 15. Researchers also monitor weight changes, anxiety and depression levels, blood electrolyte levels, liver and kidney function, thyroid function, use of intravenous fluids and additional drugs, hospital admissions, pregnancy complications, and both pregnancy and neonatal outcomes. Safety and adherence are closely observed throughout the 15-day treatment period.