NCT04278456

Brief Summary

Our aim was to diagnose and initiate early treatment for postpartum depression by detecting the changes of melatonin levels in c-sections with different antesthesia modalities.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

February 18, 2020

Last Update Submit

February 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • edinburgh depression scale

    below 12 is associated with depression

    5 months

Study Arms (3)

general anesthesia

c-section with general anesthesia

Behavioral: postpartum depression

spinal anesthesia

c-section with spinal anesthesia

Behavioral: postpartum depression

epidural anesthesia

c-section with epidural anesthesia

Behavioral: postpartum depression

Interventions

melatonin levels in c-sections with different anesthesia modalities.

epidural anesthesiageneral anesthesiaspinal anesthesia

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsaged between 18-45 years
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women that will give birth by c-section (using general or regional anesthesia) aged between 18-45 years will be included to our study

You may qualify if:

  • pregnant women c-section (using general or regional anesthesia) aged between 18-45 years

You may not qualify if:

  • age under 18 or above 45, history of smoking, a diagnosis with mental retardation, psychiatric patients, use of antipsychotics or antidepressants, patients with sleeping disorders, hormone replacement theraphy patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Byu

Erzincan, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Andersen LP, Werner MU, Rosenberg J, Gogenur I. A systematic review of peri-operative melatonin. Anaesthesia. 2014 Oct;69(10):1163-71. doi: 10.1111/anae.12717. Epub 2014 May 19.

  • Maitra S, Baidya DK, Khanna P. Melatonin in perioperative medicine: Current perspective. Saudi J Anaesth. 2013 Jul;7(3):315-21. doi: 10.4103/1658-354X.115316.

  • Dianatkhah M, Ghaeli P, Hajhossein Talasaz A, Karimi A, Salehiomran A, Bina P, Jalali A, Ghaffary S, Shahmansouri N, Vejdani S. Evaluating the Potential Effect of Melatonin on the post-Cardiac Surgery Sleep Disorder. J Tehran Heart Cent. 2015 Jul 3;10(3):122-8.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

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

Study Officials

  • Remziye Ayşenur NALBANT

    ERZİNCAN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

March 21, 2020

Primary Completion

May 21, 2020

Study Completion

July 21, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations