EEG Alterations of Uterine Contractions in the First Stage of Labor Predicting Postpartum Depression

March 22, 2022 updated by: Zhujiang Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months after childbirth.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The score of pain in 12 months after childbirth
Time Frame: up to 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.
up to 12 months after childbirth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: HongFei Zhang, MD PhD, Zhujiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

January 29, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Maternal EEG monitoring

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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