Postpartum DepressionNCT05217251
EEG Alterations of Uterine Contractions in the First Stage of Labor Predicting Postpartum Depression
An observational study of Postpartum Depression, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- frontal alpha asymmetry in EEG
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants will consist of parturient women who plan a vaginal delivery in Zhujiang hospital .
Who may be able to join
- 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.
Who cannot join
- history of neurological or psychiatric disease;
- personality disorder;
- cerebral disease;
- epidural anesthesia contraindication;
- multiparous pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guanzhou, Guangdong, 510000
HongFei Zhang, MD PhD, 8620 62787271, hongfeiz2003@163.com
FengXian Li, MD PhD, 8620 62787271, lifengxian81@outlook.com
About this study
Official title: The Values of Electroencephalography (EEG) Alterations of Uterine Contractions in the First Stage of Labor Predicting Postpartum Depression: a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- frontal alpha asymmetry in EEG
- Keywords
- electroencephalogram, uterine contractions, in the first stage of labor, Postpartum Depression, frontal alpha asymmetry
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: frontal alpha asymmetry in EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months after childbirth.
Secondary outcomes (1)
The score of pain in 12 months after childbirth
The score of pain at in 12 months after childbirth is assessed by using a Visual Analogue Scale (an 10-point scale where 0 indicates no pain and 10 the worst pain).The Visual Analogue Scale is a self-reported scale consisting of a horizontal or vertical line, usually 10 centimeters long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status . An introductory question asks the patient to express that best refers to her pain.
Measured: up to 12 months after childbirth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Mar 2022
- Primary completionFeb 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HongFei Zhang, MD PhD, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217251
- Sponsor's protocol ID
- Maternal EEG monitoring
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25455248O'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.
PubMed 23394227Deng 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.
PubMed 33348177Tian 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.
PubMed 21824665Purdon 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.
PubMed 26275092Koller-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.
PubMed 32871681de 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.
PubMed 31400570Brakowski 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.
PubMed 28458140Jesulola 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.
PubMed 28042006Quraan 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.
PubMed 24285211Nusslock 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.
PubMed 21381804Wang 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.
PubMed 39844134
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Values of Electroencephalography (EEG) Alterations of Uterine Contractions in the First Stage of Labor Predicting Postpartum Depression: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05217251
- Acronym / sponsor ID
- Maternal EEG monitoring
- Conditions
- Postpartum Depression
- Keywords
- electroencephalogram, uterine contractions, in the first stage of labor, Postpartum Depression, frontal alpha asymmetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed group | – | Other: frontal alpha asymmetry in EEGParturient 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. |
| control group | – | Other: frontal alpha asymmetry in EEGParturient 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will consist of parturient women who plan a vaginal delivery in Zhujiang hospital .
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- history of neurological or psychiatric disease;
- personality disorder;
- cerebral disease;
- epidural anesthesia contraindication;
- multiparous pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frontal alpha asymmetry in EEGfrontal 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. | Other | control group, exposed group |
Primary outcome
The incidence of depression in 12 months after childbirth.
Time frame: up to 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.
1 secondary outcome
The score of pain in 12 months after childbirth
Time frame: up to 12 months after childbirth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 25455248Howard 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.
- Background: PubMed 23394227O'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.
- Background: PubMed 33348177Deng 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.
- Background: PubMed 21824665Tian 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.
- Background: PubMed 26275092Purdon 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.
- Background: PubMed 32871681Koller-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.
- Background: PubMed 31400570de 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.
- Background: PubMed 28458140Brakowski 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.
- Background: PubMed 28042006Jesulola 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.
- Background: PubMed 24285211Quraan 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.
- Background: PubMed 21381804Nusslock 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.
- Derived from this study: PubMed 39844134Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HongFei Zhang, MD PhD principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HongFei Zhang, MD PhD (8620 62787271, hongfeiz2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of depression in 12 months after childbirth. (time frame: up to 12 months after childbirth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217251, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.