Relationship Between Postpartum Mood Disorders and Delivery Experience

February 11, 2019 updated by: Joanna Kountanis, University of Michigan
The purpose of this study is to evaluate potential risk factors for developing postpartum depression or posttraumatic stress disorder during the first year postpartum in patients who have no preexisting history of PTSD or PPD.

Study Overview

Status

Completed

Conditions

Detailed Description

It is theorized that poor pain control during labor and cesarean delivery, non-elective inductions, unplanned surgeries such as urgent/emergent cesarean delivery or operating room management of postpartum hemorrhage, and opioid abuse/addiction are risk factors for developing postpartum depression (PPD) or post-traumatic stress disorder (PTSD) after delivery. This study will, through questionnaires, interviews, and examination of the medical record, seek to identify whether and how strongly such correlations exist during the first year postpartum in patients who have no preexisting history of these conditions.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who are planning to give birth at the University of Michigan.

Description

Inclusion Criteria:

  • Woman planning on giving birth at the University of Michigan
  • Speaks English without translator
  • Live pregnancy not desiring termination
  • Smartphone owner
  • Woman whose delivery date is >28 weeks gestational age

Exclusion Criteria:

  • History of previous postpartum depression (PPD) or posttraumatic stress disorder (PTSD) from a birth experience
  • Non-English speaker requiring a translator
  • Patients who have a fetus with major fetal anomalies
  • Positive screening at 28 weeks antepartum for Edinburgh Postnatal Depression Scale (EPDS) or Primary Care PTSD (PC-PTSD) screen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of poor birth experiences with development of postpartum posttraumatic stress disorder (PTSD).
Time Frame: 1 year postpartum
Enrollees will receive questionnaires for Perinatal Posttraumatic Stress Disorder (PPQ) screenings 6 weeks, 3 months, 6 months, and 1 year postpartum. Positive screens are defined as PPQ>19. PPQ>13 will be considered as subsyndromal. At each screening, patients with positive scores will be interviewed to diagnose PTSD and to look for thematic similarities in birth experiences. Patients' medical charts will be reviewed for 4 clinical events: Pain scores >5 with a labor epidural in place; Pain during cesarean delivery requiring general anesthesia, IV narcotics, ketamine, midazolam, nitrous oxide, or reassurance; Non-elective inductions of labor; and Unplanned surgery including urgent/emergent cesarean delivery and postpartum hemorrhage requiring operating room management. Statistical analysis of all 4 PPQ scores and evaluation of clinical birth events will be performed to determine the association of poor birth experiences with postpartum depression.
1 year postpartum
Association of poor birth experience with development of postpartum depression.
Time Frame: 1 year postpartum
Enrollees will receive questionnaires for Edinburgh Postnatal Depression Scale (EPDS) screenings at 6 weeks, 3 months, 6 months, and 1 year postpartum. Positive screens are defined as EPDS score >10 or a positive response for question 10 asking about suicidality. At each screening, patients with positive scores will be interviewed to diagnose depression and to look for thematic similarities in birth experiences. Patients' medical charts will be reviewed for 4 clinical events: Pain scores >5 with a labor epidural in place; Pain during cesarean delivery requiring general anesthesia, IV narcotics, ketamine, midazolam, nitrous oxide, or reassurance; Non-elective inductions of labor; and Unplanned surgery including urgent/emergent cesarean delivery and postpartum hemorrhage requiring operating room management. Statistical analysis of all 4 EPDS scores and evaluation of clinical birth events will be performed to determine the association of poor birth experiences with postpartum depression.
1 year postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Elizabeth Langen, MD, University of Michigan
  • Principal Investigator: Joanna Kountanis, MD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2016

Primary Completion (Actual)

December 17, 2018

Study Completion (Actual)

December 17, 2018

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00119428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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