NCT06947278

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

April 12, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

prospective observational studies;Postpartum Depression(PPD)brain-derived neurotrophic factor (BDNF)Edinburgh postnatal depression scale (EPDS)Hamilton depression scale (HAMD-21)

Outcome Measures

Primary Outcomes (1)

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

    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 (2)

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

    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.

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

    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.

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective cesarean section under combined lumbar-rigid anesthesia in the First People's Hospital of Lianyungang City

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Lianyungang, Jiangsu, 222000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

cerebrospinal fluid and blood

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2025

First Posted

April 27, 2025

Study Start

May 1, 2025

Primary Completion

November 16, 2025

Study Completion

November 16, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations