- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04278456
Postpartum Depression
February 18, 2020 updated by: REMZIYE AYSENUR NALBANT, Erzincan University
The Effect of the Anesthesia Modality Used in Women Giving Birth Under Caesarian Section on Postpartum Depression and/or Postoperative Melatonin Levels
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Erzincan, Turkey
- Recruiting
- Erzincan Byu
-
Contact:
- DİDEM ONK
- Phone Number: 05053856322
- Email: d.hesapdar@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
general anesthesia
c-section with general anesthesia
|
melatonin levels in c-sections with different anesthesia modalities.
|
spinal anesthesia
c-section with spinal anesthesia
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melatonin levels in c-sections with different anesthesia modalities.
|
epidural anesthesia
c-section with epidural anesthesia
|
melatonin levels in c-sections with different anesthesia modalities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
edinburgh depression scale
Time Frame: 5 months
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below 12 is associated with depression
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5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Remziye Ayşenur NALBANT, ERZİNCAN
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 21, 2020
Primary Completion (ANTICIPATED)
May 21, 2020
Study Completion (ANTICIPATED)
July 21, 2020
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 18, 2020
First Posted (ACTUAL)
February 20, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EBYU 88
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
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University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
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University of MinnesotaNational Institute of Mental Health (NIMH)Completed
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Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
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Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
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University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
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Clinical Trials on postpartum depression
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Kanuni Sultan Suleyman Training and Research HospitalCompletedCovid19 | Pregnancy Related | Depression, AnxietyTurkey
-
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Lund UniversityRegion Skane; Föreningen Mjölkdroppen HelsingborgCompletedDepression, PostpartumSweden
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Women and Infants Hospital of Rhode IslandCompletedPostpartum Depression | Satisfaction, Patient | Breastfeeding | Postpartum Disorder | Postpartum Weight Retention | TrustUnited States
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Norwegian School of Sport SciencesThe Research Council of Norway; University Hospital, AkershusCompletedUrinary IncontinenceNorway
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Rambam Health Care CampusUnknown