A Clinical Study on the Effect of Labor Analgesia on the Postpartum Recovery Outcome of Chinese Parturients

Recruiting

• Conditions: Analgesia; Labor Analgesia

• Registration Number: NCT05666024
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

Background:

The parturient will experience extreme pain during delivery. Effective labor analgesia will bring better delivery experience to the parturient, while the adverse experience during delivery may bring many adverse effects to the parturient, including postpartum depression, insomnia, and even suicide. Postpartum depression, which has a high incidence, is one of the most common diseases that affect the quality of life of pregnant women during the perinatal period. Postpartum depression even leads to maternal suicide, which is the main cause of maternal death in the first year after childbirth. At the same time, postpartum depression seriously affects the relationship between mother and baby, which significantly increases the risk of long-term psychological sequelae of their children. Its incidence in Europe and America is about 10%, while in China it even reaches 15.7-39.8%. In addition, these factors may also affect maternal breast milk and adversely affect the psychological and behavioral development of infants. Many studies report that effective analgesia can reduce the incidence of postpartum depression in the process of natural delivery, which indicates that labor analgesia is one of the effective measures to reduce postpartum depression. However, the sample size of these studies is relatively small, and they usually focus on the psychological impact on the mothers themselves, and the focus time is only 6-8 weeks after the operation. However, there is still a lack of large sample multicenter studies on the long-term outcome of postpartum mothers and newborns (including the impact of breast feeding and neonatal neurointellectual development).

Objective:

1. The subjects were included and comprehensive perinatal data were collected. On this basis, the database of maternal and neonatal prognosis for labor analgesia was established;

2. Different data analysis methods were used to analyze the differences of maternal and neonatal outcomes to provide evidence based medical evidence for the current situation of labor analgesia and the optimization of labor analgesia mode.

Detailed Description

Based on the principle of Real World Study (RWS), this study is intended to conduct a prospective observational study through long-term comprehensive outcome follow-up of a large sample of multiple centers, and then, based on different studies, conduct a synchronous survey by gathering comprehensive attention on outcome indicators, and use machine learning, regression analysis, propensity matching and other analysis methods for data analysis, Finally, independent analysis based on different sub research topics combined with big data analysis will provide effective evidence-based medical evidence for the optimization of current labor analgesia.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

• 20 ≤ age ≤ 45;
• ASA I ～ III;
• Willing to participate in this study and sign the informed consent form.

Exclusion Criteria

• Take other trial drugs or participate in other clinical trials 3 months before inclusion in the study;
• Unable to cooperate with the research for any reason.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data collection and database establishment	2024	The subjects were included and comprehensive perinatal data were collected. On this basis, the prognostic database of parturients with labor analgesia and neonates was established

Secondary Outcome Measures

Name	Time	Method
data analysis	2024	Different data analysis methods are used to analyze the differences of maternal and neonatal outcomes, so as to provide evidence-based medical evidence for the current situation of labor analgesia and the optimization of labor analgesia mode.

Trial Locations

Locations (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China