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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04278456
Other study ID # EBYU 88
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 21, 2020
Est. completion date July 21, 2020

Study information

Verified date February 2020
Source Erzincan University
Contact DIDEM ONK
Phone 05053856322
Email d.hesapdar@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date July 21, 2020
Est. primary completion date May 21, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design


Intervention

Behavioral:
postpartum depression
melatonin levels in c-sections with different anesthesia modalities.

Locations

Country Name City State
Turkey Erzincan Byu Erzincan

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

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): — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary edinburgh depression scale below 12 is associated with depression 5 months
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