NCT02020148

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

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

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

December 12, 2013

Last Update Submit

October 24, 2023

Conditions

Keywords

pregnancyoxytocinpostpartum depressiondepressionpregnant womenmoodanxietyhormoneswomen's healthmental healthbaby bluesmood disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Pregnant Women

You may qualify if:

  • At least 18 years of age
  • English-speaking
  • Pregnant (third trimester at time of visit)

You may not qualify if:

  • Current active depression or other mental illness at time of study entry in the third trimester (past depression or anxiety is acceptable)
  • Current antidepressant treatment
  • Severe medical complications in current pregnancy (gestational diabetes, hypertension, thyroid disease)
  • Signs of multiple gestation or of fetal malformation in current pregnancy
  • Cigarette smoking beyond 10th week of gestation of current pregnancy
  • Pre-pregnancy BMI \> 32

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related 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 depression in pregnancy. Front Genet. 2015 Jul 21;6:243. doi: 10.3389/fgene.2015.00243. eCollection 2015.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

A 3 milliliter (about half a teaspoon) blood sample will be obtained to measure oxytocin level.

MeSH Terms

Conditions

Depression, PostpartumDepressionAnxiety DisordersPsychological Well-BeingMood Disorders

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMental DisordersBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Suena H Massey, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 24, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations