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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02020148
Other study ID # 00082402
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2013
Est. completion date August 2015

Study information

Verified date October 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this research study is to understand the relationship between the hormone oxytocin and postpartum mood.


Description:

Postpartum depression (PPD) affects some one in five new mothers, and adversely influences maternal adaptation to motherhood. While it is known that women with a prior history of depression, or depression during pregnancy, are at elevated risk for postpartum depression, many women with no prior history of depression or other risk factors go on to develop depression in the postpartum period. Considering the grave consequences of postpartum depression on maternal infant bonding and childhood psychological development, it is critical to develop reliable methods to identify which women, who are not depressed during pregnancy, will become depressed after delivery. The biological pathways leading to depression at any time in life, including around pregnancy, are still poorly characterized. Oxytocin (OT), a hormone involved in delivery and lactation, has received recent attention regarding its additional role in maternal emotions and care taking behaviors after birth. The primary goal is explore the relationship between plasma oxytocin and postpartum mood.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date August 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. At least 18 years of age 2. English-speaking 3. Pregnant (third trimester at time of visit) Exclusion Criteria: 1. Current active depression or other mental illness at time of study entry in the third trimester (past depression or anxiety is acceptable) 2. Current antidepressant treatment 3. Severe medical complications in current pregnancy (gestational diabetes, hypertension, thyroid disease) 4. Signs of multiple gestation or of fetal malformation in current pregnancy 5. Cigarette smoking beyond 10th week of gestation of current pregnancy 6. Pre-pregnancy BMI > 32

Study Design


Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Northwestern Memorial Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bell AF, Carter CS, Steer CD, Golding J, Davis JM, Steffen AD, Rubin LH, Lillard TS, Gregory SP, Harris JC, Connelly JJ. Interaction between oxytocin receptor DNA methylation and genotype is associated with risk of postpartum depression in women without d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Inventory of Depressive Symptomatology, Self-Report (IDS-SR-30) The IDS-SR-30 is a validated, widely used tool to evaluate depressive symptoms and clinical depression. Participants will complete this questionnaire in person or through telephone interview. 4-6 weeks post delivery
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