Postpartum Depression (PPD)NCT06947278
Preoperative Study of the Correlation Between BDNF-TrkB Signaling Pathway Expression Levels in Cerebrospinal Fluid and Blood and Postpartum Depression
An observational study of Postpartum Depression (PPD), run by The First People's Hospital of Lianyungang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Postpartum Depression (PPD)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 16 Nov 2025
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients undergoing elective cesarean section under combined lumbar-rigid anesthesia in the First People's Hospital of Lianyungang City
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Lianyungang Hospital of Xuzhou Medical University
Lianyungang, Jiangsu, 222000
About this study
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.
Read the detailed description
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.
- Conditions
- Postpartum Depression (PPD)
- Keywords
- prospective observational studies;, Postpartum Depression(PPD), brain-derived neurotrophic factor (BDNF), Edinburgh postnatal depression scale (EPDS), Hamilton depression scale (HAMD-21)
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the expression level of BDNF-TrkB signaling pathway (mBDNF, proBDNF) in cerebrospinal fluid and blood and postpartum depression;
Measured: 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;
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 May 2025
- Primary completion16 Nov 2025
- Study completion16 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947278
- Sponsor's protocol ID
- KY-20240701001-02
- Status last verified
- Nov 2025
- First submitted
- 12 Apr 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Study of the Correlation Between BDNF-TrkB Signaling Pathway Expression Levels in Cerebrospinal Fluid and Blood and Postpartum Depression
- ClinicalTrials.gov ID
- NCT06947278
- Acronym / sponsor ID
- KY-20240701001-02
- Conditions
- Postpartum Depression (PPD)
- Keywords
- prospective observational studies;, Postpartum Depression(PPD), brain-derived neurotrophic factor (BDNF), Edinburgh postnatal depression scale (EPDS), Hamilton depression scale (HAMD-21)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 16 Nov 2025 (actual)
- Study completion
- 16 Nov 2025 (actual)
- First posted
- 27 Apr 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing elective cesarean section under combined lumbar-rigid anesthesia in the First People's Hospital of Lianyungang City
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (PPD), run by The First People's Hospital of Lianyungang 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 2 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.