NCT05666024

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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

3 years

First QC Date

December 2, 2022

Last Update Submit

December 22, 2022

Conditions

Keywords

Labor analgesiaChinese parturientsPostpartum recovery

Outcome Measures

Primary Outcomes (1)

  • Data collection and database establishment

    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

    2024

Secondary Outcomes (1)

  • data analysis

    2024

Study Arms (1)

Parturients

Maternity about to give birth

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Parturients

You may qualify if:

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

You may not qualify if:

  • Unable to cooperate with the research for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (11)

  • Pollard K. MBRRACE-UK Report launch December 2016. Pract Midwife. 2017 Feb;20(2):30-2.

    PMID: 30462430BACKGROUND
  • Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, O'Connor TG, Stein A. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA Psychiatry. 2013 Dec;70(12):1312-9. doi: 10.1001/jamapsychiatry.2013.2163.

    PMID: 24108418BACKGROUND
  • Munk-Olsen T, Laursen TM, Pedersen CB, Mors O, Mortensen PB. New parents and mental disorders: a population-based register study. JAMA. 2006 Dec 6;296(21):2582-9. doi: 10.1001/jama.296.21.2582.

    PMID: 17148723BACKGROUND
  • Howard LM, Molyneaux E, Dennis CL, Rochat T, Stein A, Milgrom J. Non-psychotic mental disorders in the perinatal period. Lancet. 2014 Nov 15;384(9956):1775-88. doi: 10.1016/S0140-6736(14)61276-9. Epub 2014 Nov 14.

    PMID: 25455248BACKGROUND
  • Siu BW, Leung SS, Ip P, Hung SF, O'Hara MW. Antenatal risk factors for postnatal depression: a prospective study of Chinese women at maternal and child health centres. BMC Psychiatry. 2012 Mar 22;12:22. doi: 10.1186/1471-244X-12-22.

    PMID: 22436053BACKGROUND
  • Wang SY, Jiang XY, Jan WC, Chen CH. A comparative study of postnatal depression and its predictors in Taiwan and mainland China. Am J Obstet Gynecol. 2003 Nov;189(5):1407-12. doi: 10.1067/s0002-9378(03)00673-2.

    PMID: 14634578BACKGROUND
  • Goldbort J. Transcultural analysis of postpartum depression. MCN Am J Matern Child Nurs. 2006 Mar-Apr;31(2):121-6. doi: 10.1097/00005721-200603000-00012.

    PMID: 16523038BACKGROUND
  • Lim G, Facco FL, Nathan N, Waters JH, Wong CA, Eltzschig HK. A Review of the Impact of Obstetric Anesthesia on Maternal and Neonatal Outcomes. Anesthesiology. 2018 Jul;129(1):192-215. doi: 10.1097/ALN.0000000000002182.

    PMID: 29561267BACKGROUND
  • Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.

    PMID: 24797120BACKGROUND
  • Lim G, Farrell LM, Facco FL, Gold MS, Wasan AD. Labor Analgesia as a Predictor for Reduced Postpartum Depression Scores: A Retrospective Observational Study. Anesth Analg. 2018 May;126(5):1598-1605. doi: 10.1213/ANE.0000000000002720.

    PMID: 29239949BACKGROUND
  • Stewart DE, Vigod S. Postpartum Depression. N Engl J Med. 2016 Dec 1;375(22):2177-2186. doi: 10.1056/NEJMcp1607649. No abstract available.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xianwei Zhang, Doctor

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianwei Zhang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 27, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations