NCT04271072

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Typical duration 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

Study Start

First participant enrolled

February 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

2.1 years

First QC Date

February 7, 2020

Last Update Submit

December 14, 2023

Conditions

Perinatal DepressionChronic Pain

Keywords

NeuroinflammationBiomarkerCesarean deliveryCytokinesCerebrospinal fluid

Outcome Measures

Primary Outcomes (3)

  • Perinatal depression

    Edinburgh postnatal depression scale \>=10 (minimum 0, maximum 30, increasing score indicates higher likelihood of depression)

    Up to 3 months after delivery

  • Persistent pain: Pain score

    Pain score \>=3 at pelvic or lower abdominal areas (minimum 0, maximum 10, higher score indicates greater pain)

    Up to 3 months after delivery

  • Inflammatory cytokines/biomarkers

    Biomarkers from CSF and plasma samples will be quantified using Meso Scale Discovery multiplex kit (K15210D), for: CRP, Eotaxin, Eotaxin-3, FGF (basic), ICAM-1, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-13, IL-15, IL-16, IL-17A, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, VCAM-1, VEGF-A, VEGF-C, VEGF-D, VEGFR-1/Flt-1. The levels of these biomarkers will be compared between the group with depression/persistent pain, versus the group without depression/persistent pain.

    Up to 24 hours after surgery

Secondary Outcomes (1)

  • CSF compared to plasma inflammatory cytokines/biomarkers

    Preoperative samples

Study Arms (2)

Study

Parturients that underwent cesarean delivery and is POSITIVE for the composite outcome of either: * perinatal depression (Edinburgh postnatal depression scale \>=10 during pregnancy or within 3 months after delivery), and/or * persistent pain (pain score \>=3 at pelvic or lower abdominal areas at 3 months after delivery)

Other: No intervention

Control

Parturients that underwent cesarean delivery and is NEGATIVE for the composite outcome of both: * perinatal depression (Edinburgh postnatal depression scale \>=10 during pregnancy or within 3 months after delivery), AND * persistent pain (pain score \>=3 at pelvic or lower abdominal areas at 3 months after delivery)

Other: No intervention

Interventions

No interventionOTHER

No intervention

ControlStudy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant parturients are eligible
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Tertiary care hospital, specialist obstetric unit

You may qualify if:

  • American Society of Anesthesiologists (ASA) class 2 and 3
  • English speaking
  • years or older
  • Singleton pregnancy
  • Gestational age \> 37 weeks
  • Scheduled cesarean delivery under spinal or combined spinal epidural anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

  • Kohler CA, Freitas TH, Maes M, de Andrade NQ, Liu CS, Fernandes BS, Stubbs B, Solmi M, Veronese N, Herrmann N, Raison CL, Miller BJ, Lanctot KL, Carvalho AF. Peripheral cytokine and chemokine alterations in depression: a meta-analysis of 82 studies. Acta Psychiatr Scand. 2017 May;135(5):373-387. doi: 10.1111/acps.12698. Epub 2017 Jan 25.

    PMID: 28122130BACKGROUND

  • Miller ES, Sakowicz A, Roy A, Yang A, Sullivan JT, Grobman WA, Wisner KL. Plasma and cerebrospinal fluid inflammatory cytokines in perinatal depression. Am J Obstet Gynecol. 2019 Mar;220(3):271.e1-271.e10. doi: 10.1016/j.ajog.2018.12.015. Epub 2018 Dec 14.

    PMID: 30557551BACKGROUND

  • Osborne LM, Monk C. Perinatal depression--the fourth inflammatory morbidity of pregnancy?: Theory and literature review. Psychoneuroendocrinology. 2013 Oct;38(10):1929-52. doi: 10.1016/j.psyneuen.2013.03.019. Epub 2013 Apr 20.

    PMID: 23608136BACKGROUND

  • Dowlati Y, Herrmann N, Swardfager W, Liu H, Sham L, Reim EK, Lanctot KL. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010 Mar 1;67(5):446-57. doi: 10.1016/j.biopsych.2009.09.033. Epub 2009 Dec 16.

    PMID: 20015486BACKGROUND

  • Ji RR, Nackley A, Huh Y, Terrando N, Maixner W. Neuroinflammation and Central Sensitization in Chronic and Widespread Pain. Anesthesiology. 2018 Aug;129(2):343-366. doi: 10.1097/ALN.0000000000002130.

    PMID: 29462012BACKGROUND

  • Yurashevich M, Cooter Wright M, Sims SC, Tan HS, Berger M, Ji RR, Habib AS. Inflammatory changes in the plasma and cerebrospinal fluid of patients with persistent pain and postpartum depression after elective Cesarean delivery: an exploratory prospective cohort study. Can J Anaesth. 2023 Dec;70(12):1917-1927. doi: 10.1007/s12630-023-02603-2. Epub 2023 Nov 6.

    PMID: 37932648DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and CSF samples

MeSH Terms

Conditions

Chronic PainNeuroinflammatory Diseases

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System DiseasesInflammationPathologic Processes

Study Officials

  • Mary Yurashevich

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 17, 2020

Study Start

February 1, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)