Oxytocin DeficiencyNCT04427410
The Relationship Between Oxytocin Level and Postpartum Depression
An observational study of Oxytocin Deficiency and Postpartum Depression, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxytocin Deficiency, Postpartum Depression, Prenatal Stress
- What is being tested?
- Salivary test
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2019to 20 Feb 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Based on the study conducted by Eapen et al. (2014), for the relationship between oxytocin and postpartum depression symptoms, based on the correlation coefficient for the periods during and after pregnancy; For r = -0.35, a minimum sample size of 61 with 5% error and 80% power has been determined. Since there may be a quit situation during the study, the sample size was determined as 67 by expanding it with a share of 10%.
Who may be able to join
- 18 years of age or older, and having a pregnancy of 30 weeks or more
Who cannot join
- previous mental illness history, miscarriage or stillbirth history, multiple pregnancy, fetal malformation, antidepressant or anxiolytic drug use, existing chronic disease,preterm labor is the development of maternal or neonatal complications at birth, hospitalization in the neonatal intensive care unit or congenital disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Oxytocin Level Measured During Pregnancy and Postpartum Depression Symptoms
There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms.
Read the detailed description
Introduction and purpose: There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms.
Method: The study was conducted with 70 women who met the research criteria. Data collection was done in two interviews. The first meeting is 30-38 at the week of gestation, the second interview is 4-12 at the week of postpartum. It was done between weeks. In each interview, a data collection form was applied first and then a saliva sample was taken. Data collection form; The questions prepared by the researchers consisted of the Edinburgh Postnatal Depression Scale (EPDS) and Beck Depression Inventory (BDI). The data were analyzed using SPSS 22.0 program and the significance value was taken as p <0.05.
- Conditions
- Oxytocin Deficiency, Postpartum Depression, Prenatal Stress
- Being tested
- Salivary test
- Keywords
- oxytocin, Postpartum Depression, oxytocin and depression
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary testDiagnostic test
Also called survey application
Salivary test for measured of oxytocin levels
| Study group | Role | What they receive |
|---|---|---|
| pregnancy | Not described Receives: Diagnostic Test: Salivary test | |
| postpartum | Not described Receives: Diagnostic Test: Salivary test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin levels
Oxytocin levels in pregnancy and postpartum period
Measured: 3-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start20 Jul 2019
- Primary completion20 Oct 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxytocin DeficiencyStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Ayseren Cevik
- Responsible party
- Principal investigator, Sultan Alan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427410
- Sponsor's protocol ID
- TYL-2019-12476
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Oxytocin Level Measured During Pregnancy and Postpartum Depression Symptoms
- ClinicalTrials.gov ID
- NCT04427410
- Acronym / sponsor ID
- TYL-2019-12476
- Conditions
- Oxytocin Deficiency, Postpartum Depression, Prenatal Stress
- Keywords
- oxytocin, Postpartum Depression, oxytocin and depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Ayseren Cevik
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 11 Jun 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.
There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms.
Detailed description
Introduction and purpose: There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms.
Method: The study was conducted with 70 women who met the research criteria. Data collection was done in two interviews. The first meeting is 30-38 at the week of gestation, the second interview is 4-12 at the week of postpartum. It was done between weeks. In each interview, a data collection form was applied first and then a saliva sample was taken. Data collection form; The questions prepared by the researchers consisted of the Edinburgh Postnatal Depression Scale (EPDS) and Beck Depression Inventory (BDI). The data were analyzed using SPSS 22.0 program and the significance value was taken as p <0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnancy | – | Diagnostic Test: Salivary test |
| postpartum | – | Diagnostic Test: Salivary test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Based on the study conducted by Eapen et al. (2014), for the relationship between oxytocin and postpartum depression symptoms, based on the correlation coefficient for the periods during and after pregnancy; For r = -0.35, a minimum sample size of 61 with 5% error and 80% power has been determined. Since there may be a quit situation during the study, the sample size was determined as 67 by expanding it with a share of 10%.
Key inclusion criteria (1 listed)
- 18 years of age or older, and having a pregnancy of 30 weeks or more
Key exclusion criteria (1 listed)
- previous mental illness history, miscarriage or stillbirth history, multiple pregnancy, fetal malformation, antidepressant or anxiolytic drug use, existing chronic disease,preterm labor is the development of maternal or neonatal complications at birth, hospitalization in the neonatal intensive care unit or congenital disease.
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 |
|---|---|---|
| Salivary testAlso: survey applicationSalivary test for measured of oxytocin levels | Diagnostic test | postpartum, pregnancy |
Primary outcome
Oxytocin levels
Time frame: 3-6 month
Oxytocin levels in pregnancy and postpartum period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Oxytocin Deficiency
RecruitingEarly Phase 1
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Arginine Vasopressin Deficiency, Oxytocin Deficiency
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
Recruiting
Plasma Oxytocin Response to Oral Estrogens in Healthy Controls and AVP-Deficiency
AVP Deficiency, Diabetes Insipidus
RecruitingPhase 2
Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
Central Diabetes Insipidus (cDI)
Recruiting
Plasma Oxytocin Changes in Response to Music Modified by Sonic Augmentation Technology
Sonic Augmentation Technology
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oxytocin Deficiency and Postpartum Depression, run by Cukurova 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxytocin levels (time frame: 3-6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.