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Recruiting NCT06704490

Analysis of the Incidence and Risk Factors of Chronic Pain After Cesarean Section

— Observational Postoperative Pain Cesarean Section Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cesarean section.
Who it may be relevant to
Registry conditions: Postoperative Pain, Cesarean Section Surgery. Basic parameters: 20 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Persistent postoperative pain is a globally recognized issue that deserves attention. Cesarean section is one of the surgeries that may cause persistent postoperative pain. PSPP may affect communication between mother and baby, and may lead to postpartum depression, which has a negative impact on the daily activities and quality of life of mothers. It is an important clinical issue. The main purpose of this study is to (1) prospectively investigate the overall incidence and characteristics of persistent pain after cesarean section at 3, 6, and 12 months after surgery; (2) Use regression analysis and data modeling analysis to evaluate the relationship between perioperative variables and chronic pain in postpartum women undergoing cesarean section; (3) Analyze the relationship between chronic pain after cesarean section and postpartum depression in postpartum women.

Interventions

  • Other Cesarean section
    Observational study without intervention

Primary outcome measures

  • Incidence of chronic pain after caesarean section [Time frame: 2024-01-01-2025-01-01]
Secondary outcome measures (3)
  • Identification of high-risk factors for postoperative inadequate analgesia and PONV in obstetric patients based on machine learning methods [Time frame: 2024-2026]
  • Adverse effects of postoperative analgesia [Time frame: 2024-2026]
  • Checklist for Chronic pain after cesarean section [Time frame: 2024-2026]

Eligibility criteria

Inclusion criteria

  • Age range from 20 to 50 years old;
  • ASA grades I to III;
  • Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;
  • Pregnant women who are willing to participate in this study and sign informed consent forms.

Exclusion criteria

  • Have a history of dementia, mental illness, or any central nervous system disorder;
  • Pregnant women who are addicted to alcohol and drugs;
  • Difficulty in follow-up or poor patient compliance;
  • Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;
  • Serious complications occur during delivery;
  • Unable to cooperate with the research for any reason.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Tongji hospital — Wuhan

Publications

  • Betran AP, Temmerman M, Kingdon C, Mohiddin A, Opiyo N, Torloni MR, Zhang J, Musana O, Wanyonyi SZ, Gulmezoglu AM, Downe S. Interventions to reduce unnecessary caesarean sections in healthy women and babies. Lancet. 2018 Oct 13;392(10155):1358-1368. doi: 10.1016/S0140-6736(18)31927-5. PMID 30322586
  • Klemetti R, Che X, Gao Y, Raven J, Wu Z, Tang S, Hemminki E. Cesarean section delivery among primiparous women in rural China: an emerging epidemic. Am J Obstet Gynecol. 2010 Jan;202(1):65.e1-6. doi: 10.1016/j.ajog.2009.08.032. Epub 2009 Oct 12. PMID 19819416
  • Lumbiganon P, Laopaiboon M, Gulmezoglu AM, Souza JP, Taneepanichskul S, Ruyan P, Attygalle DE, Shrestha N, Mori R, Nguyen DH, Hoang TB, Rathavy T, Chuyun K, Cheang K, Festin M, Udomprasertgul V, Germar MJ, Yanqiu G, Roy M, Carroli G, Ba-Thike K, Filatova E, Villar J; World Health Organization Global Survey on Maternal and Perinatal Health Research Group. Method of delivery and pregnancy outcomes i PMID 20071021
  • Li HT, Luo S, Trasande L, Hellerstein S, Kang C, Li JX, Zhang Y, Liu JM, Blustein J. Geographic Variations and Temporal Trends in Cesarean Delivery Rates in China, 2008-2014. JAMA. 2017 Jan 3;317(1):69-76. doi: 10.1001/jama.2016.18663. PMID 28030701
  • Zhang Y, Betran AP, Li X, Liu D, Yuan N, Shang L, Lin W, Tu S, Wang L, Wu X, Zhu T, Zhang Y, Lu Z, Zheng L, Gu C, Fang J, Liu Z, Ma L, Cai Z, Yang X, Li H, Zhang H, Zhao X, Yan L, Wang L, Sun X, Luo Q, Liu L, Zhu J, Qin W, Yao Q, Dong S, Yang Y, Cui Z, He Y, Feng X, He L, Zhang H, Zhang L, Wang X, Souza JP, Qi H, Duan T, Zhang J. What is an appropriate caesarean delivery rate for China: a multicen PMID 34559941
  • Sharpe EE, Booth JL, Houle TT, Pan PH, Harris LC, Aschenbrenner CA, Eisenach JC. Recovery of physical activity after cesarean delivery and its relationship with pain. Pain. 2019 Oct;160(10):2350-2357. doi: 10.1097/j.pain.0000000000001628. PMID 31145215

Identifiers

NCT: NCT06704490 · chronic postoperative pain

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗