NCT04427410

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 20, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 8, 2020

Last Update Submit

June 10, 2020

Conditions

Oxytocin DeficiencyPostpartum DepressionPrenatal Stress

Keywords

oxytocinPostpartum Depressionoxytocin and depression

Outcome Measures

Primary Outcomes (1)

  • Oxytocin levels

    Oxytocin levels in pregnancy and postpartum period

    3-6 month

Study Arms (2)

pregnancy

Diagnostic Test: Salivary test

postpartum

Diagnostic Test: Salivary test

Interventions

Salivary testDIAGNOSTIC_TEST

Salivary test for measured of oxytocin levels

Also known as: survey application
postpartumpregnancy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy and postpartum period
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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%.

You may qualify if:

  • years of age or older, and having a pregnancy of 30 weeks or more

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Saricam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, PostpartumDepression

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

July 20, 2019

Primary Completion

October 20, 2019

Study Completion

February 20, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)