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

Recruiting

• Conditions: Postpartum Depression
• Interventions: Other: frontal alpha asymmetry in EEG

• Registration Number: NCT05217251
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-01-29
• Study First Posted: 2022-02-01
• Study Start: 2022-03-01
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23
• Primary Completion: 2023-02
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 330

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
exposed group	frontal alpha asymmetry in EEG	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.
control group	frontal alpha asymmetry in EEG	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.

Primary Outcome Measures

Name	Time	Method
The incidence of depression in 12 months after childbirth.	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.

Secondary Outcome Measures

Name	Time	Method
The score of pain in 12 months after childbirth	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.

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guanzhou, Guangdong, China