Acupuncture for the Management of Postpartum Uterine Contraction Pain Following Vaginal Delivery: A Protocol for a Randomized, Sham-Controlled Trial

Purpose: Vaginal delivery is the most common mode of childbirth, and women often experience severe uterine contraction pain (UCP) for several days postpartum, which can significantly impair postpartum recovery. Acupuncture has proven efficacy in the management of multiple pain conditions. This trial aimed to evaluate the analgesic efficacy and safety of acupuncture for managing postpartum UCP following vaginal delivery. Patients and Methods: This trial was designed as a prospective, randomized controlled trial with blinding of participants, outcome assessors, and data analysts. A total of 236 participants were planned for recruitment and were randomly assigned in a 1:1 ratio to either the Verum Acupuncture (VA) group or the Sham Acupuncture (SA) group. The VA group underwent verum acupuncture at four bilateral acupoints (ST36, LR3, SP8, and GB41), for a total of eight needling sites. The SA group received simulated needling with a non-penetrating blunt needle via the Park Sham Device (PSD). Acupuncture was administered twice daily for three consecutive days, starting on the day of vaginal delivery, with needles retained for 30 minutes per session. The primary outcome was defined as the UCP level assessed by the Visual Analog Scale (VAS) on postpartum day 3. Secondary outcomes included UCP levels at postpartum days 1, 2, 10, and 17, as well as the intensity, frequency, and duration of UCP, vaginal blood loss, lactation volume, and psychological scores measured by the Edinburgh Postnatal Depression Scale (EPDS), Self-Rating Anxiety Scale (SAS), and Short Form-36 Health Survey (SF-36). Conclusion: The research results are expected to provide credible evidence for the efficacy of acupuncture as a complementary treatment for UCP following vaginal delivery. Keywords: acupuncture, uterine contraction pain, randomized controlled trial, vaginal delivery, non-pharmacological intervention