Clinical trial NCT05217251: EEG Alterations of Uterine Contractions in the First Stage of Labor Predicting Postpartum Depression
Official title: The Values of Electroencephalography (EEG) Alterations of Uterine Contractions in the First Stage of Labor Predicting Postpartum Depression: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Depression
Keywords: electroencephalogram
uterine contractions
in the first stage of labor
Postpartum Depression
frontal alpha asymmetry
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will consist of parturient women who plan a vaginal delivery in Zhujiang hospital .

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.

Detailed description: Severe uterine contractions in labor can trigger emotional disorders including postpartum depression in women during the puerperium. It is characterized by lack of motivation and behavioral changes, potentially producing serious negative consequences for offspring.

In addition, EEG alpha asymmetry is one of the commonly studied biomarkers for depression. There are multiple previous studies regarding the symmetry of EEG in left and right brain hemispheres, especially at frontal electrodes. Besides, there are many other EEG indicators that predict depression which are also likely to be strong contributors to postpartum depression.

The objective of study is to investigate if there is any association between EEG alterations of uterine contractions in the first stage of labor and factors that are associated with postpartum depression.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: The incidence of depression in 12 months after childbirth.
timeFrame: up to 12 months after childbirth.
Secondary outcomes:
measure: The score of pain in 12 months after childbirth
timeFrame: up to 12 months after childbirth.
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: HongFei Zhang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.