Evaluating the Safety and Effectiveness of Thumbtack Needle for Treating Nausea and Vomiting in Pregnancy in Women Aged 20 to 45

What this Trial Is About

Nausea and vomiting in pregnancy NVP is a common and challenging problem during the first trimester, affecting the quality of life for many pregnant women. This research aims to evaluate the clinical effectiveness and safety of thumbtack needle TN therapy, a type of acupuncture, for treating NVP. The study is a multi-center, large-sample, randomized, controlled, and triple-blinded clinical trial designed to provide high-quality evidence on this treatment. The trial compares thumbtack needle therapy with a sham thumbtack needle treatment. TN involves applying small intradermal needles to specific acupuncture points, which are kept in place for 3 days with patients pressing the needles multiple times daily. Treatments occur every 3 days for a total of 5 sessions over 15 days. The sham treatment mimics the procedure without actual needle penetration and without pressing during retention. Participants will be closely monitored throughout the study with assessments including nausea and vomiting severity, quality of life, anxiety, depression, sleep quality, weight changes, blood tests for electrolytes, liver and kidney function, thyroid hormones, and pregnancy and neonatal outcomes. Safety and patient satisfaction will also be evaluated. The primary outcome is the change in nausea and vomiting severity measured by the PUQE scale from baseline to day 15. Follow-up continues up to 42 days postpartum to observe pregnancy complications and neonatal health.

Thumbtack Needle in the Treatment of NVP