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NCT Number: NCT06947278

Preoperative Study of the Correlation Between BDNF-TrkB Signaling Pathway Expression Levels in Cerebrospinal Fluid and Blood and Postpartum Depression

This single-center prospective observational study will screen 200 parturients with combined lumbo-epidural anesthesia in the First People's Hospital of Lianyungang City, collect the basic information of the patients, as well as the scores of PSQI, STAI, NRS, SSRS and other scales one day before surgery, and analyze their effects on the expression level of BDNF. On the day of surgery, 10mL of peripheral arterial blood and 3 mL of cerebrospinal fluid were collected, and the expression levels of BDNF-TrkB signaling pathway (ProBDNF, mBDNF, TrkB, P-CREB and ALB) were measured, respectively. The patient's EPDS and HAMD-21 scores were evaluated and collected by a professional psychologist at 1 day before surgery, 7 days after surgery, and 42 days after surgery, and the correlation between BDNF expression level and the occurrence of postpartum depression was statistically analyzed, as well as which in cerebrospinal fluid and blood was more sensitive for predicting postpartum depression.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Lianyungang, Jiangsu, 222000, China

About this study

On the day before delivery, the anterior will explain the purpose of the test to the pregnant woman during the preoperative follow-up, and collect the basic information of the pregnant woman (age, gender, BMI, gestational age, education level, economic status) and the scores of PSQI, STAI, NRS, SSRS and other scales after obtaining the consent of the pregnant woman and signing the informed consent form. On the day of surgery, an anesthesiologist with more than five years of work experience collected 3ml of peripheral blood and 0.5ml of cerebrospinal fluid before anesthesia administration, and measured the expression level of BDNF-TrkB signaling pathway (ProBDNF, mBDN). 1 day before delivery, 7 days and 42 days postpartum were evaluated by a psychologist with more than five years of work experience and collected the patient's EPDS and HAMD-21 scores, the data collection for 1 day before delivery was carried out in the ward, and the follow-up at 7 days and 42 days after delivery was carried out through WeChat questionnaire link and telephone, if no response was received, WeChat contact and phone reminder would be made again after 1 and 2 weeks, if there was still no response, the subject was considered to have missed the postoperative follow-up time and was regarded as missing follow-up, Statistical analysis was performed to analyze the correlation between BDNF expression level and the occurrence of postpartum depression, and which was higher in cerebrospinal fluid and blood for predicting postpartum depression. If the EPDS score is ≥ 9 points, the HAMD-21 score is ≥ 9 points, and the mother has no suicidal tendencies, psychologists will provide psychological support treatment until the score returns to normal; If the woman is suicidal, it is recommended that the patient and her family have agreed to be admitted to the hospital. Subject files will be kept for up to 5 years after the study is completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the indications for cesarean section and have no contraindications to neuraxial anesthesia;
  • 20 years old≤ age ≤ 35 years old;
  • 37≤ gestational age< 42;
  • American Society of Anesthesiologists (ASA) grade II~III;
  • singleton pregnancy;
  • Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

  • Unable to understand the content of the questionnaire correctly;
  • a clear history of mental illness, depression, cognitive impairment and other diseases;
  • Patients who have been taking sedative, analgesic and psychotropic drugs for a long time;
  • Those who have recently used glucocorticoids or immunosuppressants;
  • Those who are allergic to or have contraindications to any of the drugs used in this study;
  • Serious pregnancy complications, such as preeclampsia, placental hyperplasia, etc.;
  • Participated in other clinical studies within the last 3 months.

Treatment and study plan

Primary outcomes

  1. Correlation between the expression level of BDNF-TrkB signaling pathway (mBDNF, proBDNF) in cerebrospinal fluid and blood and postpartum depression;

    Time frame: Blood and cerebrospinal fluid samples were collected before anesthesia administration on the day of surgery, placed in a -80 degree Celsius freezer, and mBDNF and proBDNF concentrations were measured within 3 months after sample collection.

Secondary outcomes

  1. Comparison of the sensitivity of cerebrospinal fluid and blood levels of BDNF in predicting postpartum depression;

    Time frame: Blood and cerebrospinal fluid samples were collected before anesthesia administration on the day of surgery, placed in a -80 degree Celsius freezer, and BDNF concentrations were measured within 3 months after sample collection.

  2. The correlation between BDNF (mBDNF, proBDNF) concentrations in cerebrospinal fluid and blood.

    Time frame: Blood and cerebrospinal fluid samples were collected before anesthesia administration on the day of surgery, placed in a -80 degree Celsius freezer, and albumin concentrations were measured within 3 months after sample collection.

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Lianyungang

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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