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

NCT ID: NCT06704490

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Cesarean Section Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cesarean section surgery

Observational research

Cesarean section

Intervention Type OTHER

Observational study without intervention

Interventions

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Cesarean section

Observational study without intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xianwei Zhang,MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xianwei Zhang, Doctor

Role: CONTACT

13296696810

Facility Contacts

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Xianwei Zhang, Professor

Role: primary

13296696810

References

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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.

Reference Type RESULT
PMID: 30322586 (View on PubMed)

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.

Reference Type RESULT
PMID: 19819416 (View on PubMed)

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 in Asia: the WHO global survey on maternal and perinatal health 2007-08. Lancet. 2010 Feb 6;375(9713):490-9. doi: 10.1016/S0140-6736(09)61870-5. Epub 2010 Jan 11.

Reference Type RESULT
PMID: 20071021 (View on PubMed)

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.

Reference Type RESULT
PMID: 28030701 (View on PubMed)

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 multicentre survey. BJOG. 2022 Jan;129(1):138-147. doi: 10.1111/1471-0528.16951. Epub 2021 Oct 26.

Reference Type RESULT
PMID: 34559941 (View on PubMed)

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.

Reference Type RESULT
PMID: 31145215 (View on PubMed)

Other Identifiers

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chronic postoperative pain

Identifier Type: -

Identifier Source: org_study_id

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