Postpartum DepressionNCT04278456
Postpartum Depression
An observational study of Postpartum Depression and Melatonin, run by Erzincan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Depression, Melatonin
- What is being tested?
- postpartum depression
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2020to 21 Jul 2020
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- pregnant women c-section (using general or regional anesthesia) aged between 18-45 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzincan Byu
Erzincan
DİDEM ONK, 05053856322, d.hesapdar@gmail.com
About this study
Official title: 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.
- Conditions
- Postpartum Depression, Melatonin
- Being tested
- postpartum depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postpartum depressionBehavioural
melatonin levels in c-sections with different anesthesia modalities.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | c-section with general anesthesia Receives: Behavioral: postpartum depression | |
| spinal anesthesia | c-section with spinal anesthesia Receives: Behavioral: postpartum depression | |
| epidural anesthesia | c-section with epidural anesthesia Receives: Behavioral: postpartum depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
edinburgh depression scale
below 12 is associated with depression
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start21 Mar 2020 (estimated)
- Primary completion21 May 2020 (estimated)
- Study completion21 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, REMZIYE AYSENUR NALBANT, Erzincan University
- Investigators
- Remziye Ayşenur NALBANT, Principal investigator, ERZİNCAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278456
- Sponsor's protocol ID
- EBYU 88
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24835540Maitra 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.
PubMed 24015137Dianatkhah 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.
PubMed 26697084
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Anesthesia Modality Used in Women Giving Birth Under Caesarian Section on Postpartum Depression and/or Postoperative Melatonin Levels
- ClinicalTrials.gov ID
- NCT04278456
- Acronym / sponsor ID
- EBYU 88
- Conditions
- Postpartum Depression, Melatonin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 21 Mar 2020 (estimated)
- Primary completion
- 21 May 2020 (estimated)
- Study completion
- 21 Jul 2020 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | – | Behavioral: postpartum depressionc-section with general anesthesia |
| spinal anesthesia | – | Behavioral: postpartum depressionc-section with spinal anesthesia |
| epidural anesthesia | – | Behavioral: postpartum depressionc-section with epidural anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- pregnant women c-section (using general or regional anesthesia) aged between 18-45 years
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postpartum depressionmelatonin levels in c-sections with different anesthesia modalities. | Behavioural | epidural anesthesia, general anesthesia, spinal anesthesia |
Primary outcome
edinburgh depression scale
Time frame: 5 months
below 12 is associated with depression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Results publication: PubMed 24835540Andersen 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.
- Results publication: PubMed 24015137Maitra 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.
- Results publication: PubMed 26697084Dianatkhah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remziye Ayşenur NALBANT principal investigator
ERZİNCAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression and Melatonin, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DİDEM ONK (05053856322, d.hesapdar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
edinburgh depression scale (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278456, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.