CompletedNot Applicable

CSF/Serum Biomarkers in Predicting PND/Persistent Pain After Cesarean

United States81 participantsStarted 2020-02-01

Plain-language summary

The aim is to investigate if inflammatory biomarkers in the blood and cerebrospinal fluid (CSF) are associated with the development of perinatal depression and/or persistent pain after cesarean delivery. This study will obtain CSF and blood samples in 70 parturients. All parturients will be assessed for perinatal depression and persistent pain, and the presence/absence of these outcomes will be correlated to changes in the inflammatory biomarkers within the samples collected. If present, consistent changes in biomarkers correlating with perinatal depression or persistent pain may be utilised as a predictive tool and facilitate early treatment for these conditions.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * American Society of Anesthesiologists (ASA) class 2 and 3 * English speaking * 18 years or older * Singleton pregnancy * Gestational age \> 37 weeks * Scheduled cesarean delivery under spinal or combined spinal epidural anesthesia Exclusion Criteria: * Intravenous drug or chronic opioid use * Anti-depressant or anxiolytic drug use * Allergy to standard of care drugs * Cesarean delivery under general anesthesia or epidural anesthesia * Pre-eclampsia needing magnesium sulfate * Chronic PO/IV analgesic or glucocorticoids * History of chronic pain syndromes

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perinatal depression

Timeframe: Up to 3 months after delivery

Persistent pain: Pain score

Timeframe: Up to 3 months after delivery

Inflammatory cytokines/biomarkers

Timeframe: Up to 24 hours after surgery

Trial details

NCT IDNCT04271072

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-28

View on ClinicalTrials.gov More Perinatal Depression trials