NCT05217251

Brief Summary

Severe uterine contractions in labor can trigger emotional disorders including postpartum depression in women during the puerperium. Numerous studies have shown that resting frontal electroencephalogram (EEG) asymmetry is closely related to depression. Therefore, the investigators hypothesize that the frontal alpha asymmetry in EEG during uterine contractions in the first stage of labor be associated with the risk level of postpartum depression. The objective of this research is to investigate, in a 1-year period, the incidence of postpartum depression in natural birth mothers in relation to frontal alpha asymmetry in EEG during uterine contractions and resting state.

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
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

First Submitted

Initial submission to the registry

January 16, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 23, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

January 16, 2022

Last Update Submit

March 22, 2022

Conditions

Postpartum Depression

Keywords

electroencephalogramuterine contractionsin the first stage of laborPostpartum Depressionfrontal alpha asymmetry

Outcome Measures

Primary Outcomes (1)

  • The incidence of depression in 12 months after childbirth.

    Postpartum depression in 12 months is diagnosed by using Edinburgh Postpartum Depression Scale (EPDS) by a research assistant. the threshold of postpartum depression is defined as a score of ≥10.The EPDS is a 10-item self-report scale to screen for Postnatal Depression. The EPDS is found to have satisfactory sensitivity and specificity, and is also sensitive to change in the severity of depression over time. Each question is on a scale of 0 to 3. The EPDS has a score range between 0 to 30, with a higher score reflecting higher symptom severity in depression.

    up to 12 months after childbirth.

Secondary Outcomes (1)

  • The score of pain in 12 months after childbirth

    up to 12 months after childbirth.

Study Arms (2)

exposed group

Parturient women will be identified with frontal alpha asymmetry based on EEG monitoring of uterine contractions in the first stage of labor and will then be allocated to vaginal delivery with alpha asymmetry group in hospital.

Other: frontal alpha asymmetry in EEG

control group

Parturient women will be identified without frontal alpha asymmetry based on EEG monitoring of uterine contractions in the first stage of labor and will then be allocated to vaginal delivery without alpha asymmetry group in hospital.

Other: frontal alpha asymmetry in EEG

Interventions

frontal alpha asymmetry in EEGOTHER

frontal alpha asymmetry based on EEG monitoring of uterine contractions in the first stage of labor. The power spectra will be log-transformed and averaged across the frontal left (FL) channels (FP1, F3, F7) and frontal right (FR) channels (FP2, F4, F8). A higher power spectrum value indicates lower neural activity. Frontal asymmetry (FA) power scores are calculated as follows, FA = (FR-FL)/(FR+FL). A positive FA value shows greater neural activity in the left frontal lobe than right frontal neural activity (relative left frontal asymmetry), while its negative value shows oppositely.

control groupexposed group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will consist of parturient women who plan a vaginal delivery in Zhujiang hospital .

You may qualify if:

  • parturient women with a singleton pregnancy;
  • capable of understanding the research requirements and willing to cooperate with the study instructions;
  • aged 18-45;
  • American Society of Anesthesiologists(ASA) physical status I or II;
  • right handed;
  • not taking any drug known to influence the EEG;
  • EPDS scale (Edinburgh Postnatal Depression Scale, EPDS) is used in the last prenatal examination in outpatient clinics , with scores \< 10;
  • informed consent is gained from all individual subjects taking part in the study.

You may not qualify if:

  • history of neurological or psychiatric disease;
  • personality disorder;
  • cerebral disease;
  • epidural anesthesia contraindication;
  • multiparous pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital

Guanzhou, Guangdong, 510000, China

RECRUITING

Related Publications (12)

  • 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

  • O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.

    PMID: 23394227BACKGROUND

  • Deng CM, Ding T, Li S, Lei B, Xu MJ, Wang L, Xu SC, Yang HX, Sun XY, Li XY, Ma D, Wang DX. Neuraxial labor analgesia is associated with a reduced risk of postpartum depression: A multicenter prospective cohort study with propensity score matching. J Affect Disord. 2021 Feb 15;281:342-350. doi: 10.1016/j.jad.2020.12.027. Epub 2020 Dec 8.

    PMID: 33348177BACKGROUND

  • Tian T, Li Y, Xie D, Shen Y, Ren J, Wu W, Guan C, Zhang Z, Zhang D, Gao C, Zhang X, Wu J, Deng H, Wang G, Zhang Y, Shao Y, Rong H, Gan Z, Sun Y, Hu B, Pan J, Li Y, Sun S, Song L, Fan X, Li Y, Zhao X, Yang B, Lv L, Chen Y, Wang X, Ning Y, Shi S, Chen Y, Kendler KS, Flint J, Tian H. Clinical features and risk factors for post-partum depression in a large cohort of Chinese women with recurrent major depressive disorder. J Affect Disord. 2012 Feb;136(3):983-7. doi: 10.1016/j.jad.2011.06.047. Epub 2011 Aug 7.

    PMID: 21824665BACKGROUND

  • Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.

    PMID: 26275092BACKGROUND

  • Koller-Schlaud K, Strohle A, Barwolf E, Behr J, Rentzsch J. EEG Frontal Asymmetry and Theta Power in Unipolar and Bipolar Depression. J Affect Disord. 2020 Nov 1;276:501-510. doi: 10.1016/j.jad.2020.07.011. Epub 2020 Jul 10.

    PMID: 32871681BACKGROUND

  • de Aguiar Neto FS, Rosa JLG. Depression biomarkers using non-invasive EEG: A review. Neurosci Biobehav Rev. 2019 Oct;105:83-93. doi: 10.1016/j.neubiorev.2019.07.021. Epub 2019 Aug 7.

    PMID: 31400570BACKGROUND

  • Brakowski J, Spinelli S, Dorig N, Bosch OG, Manoliu A, Holtforth MG, Seifritz E. Resting state brain network function in major depression - Depression symptomatology, antidepressant treatment effects, future research. J Psychiatr Res. 2017 Sep;92:147-159. doi: 10.1016/j.jpsychires.2017.04.007. Epub 2017 Apr 24.

    PMID: 28458140BACKGROUND

  • Jesulola E, Sharpley CF, Agnew LL. The effects of gender and depression severity on the association between alpha asymmetry and depression across four brain regions. Behav Brain Res. 2017 Mar 15;321:232-239. doi: 10.1016/j.bbr.2016.12.035. Epub 2016 Dec 29.

    PMID: 28042006BACKGROUND

  • Quraan MA, Protzner AB, Daskalakis ZJ, Giacobbe P, Tang CW, Kennedy SH, Lozano AM, McAndrews MP. EEG power asymmetry and functional connectivity as a marker of treatment effectiveness in DBS surgery for depression. Neuropsychopharmacology. 2014 Apr;39(5):1270-81. doi: 10.1038/npp.2013.330. Epub 2013 Nov 28.

    PMID: 24285211BACKGROUND

  • Nusslock R, Shackman AJ, Harmon-Jones E, Alloy LB, Coan JA, Abramson LY. Cognitive vulnerability and frontal brain asymmetry: common predictors of first prospective depressive episode. J Abnorm Psychol. 2011 May;120(2):497-503. doi: 10.1037/a0022940.

    PMID: 21381804BACKGROUND

  • Wang Y, He WY, Zhan CAA, Pan SL, Wu W, Li FX, Zhang HF. Protocol for prognosticating PPD using EEG changes during labor pain by uterine contractions: a prospective cohort study in the first stage of labor. BMC Pregnancy Childbirth. 2025 Jan 22;25(1):49. doi: 10.1186/s12884-025-07167-1.

    PMID: 39844134DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • HongFei Zhang, MD PhD

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HongFei Zhang, MD PhD

CONTACT

8620 62787271hongfeiz2003@163.com

FengXian Li, MD PhD

CONTACT

8620 62787271lifengxian81@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2022

First Posted

February 1, 2022

Study Start

March 1, 2022

Primary Completion

February 1, 2023

Study Completion

December 1, 2024

Last Updated

March 23, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)