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Trial record 47 of 49 for:    Postpartum Depression AND PPD | "Depression" AND "Depression"

Relationship Between Postpartum Mood Disorders and Delivery Experience

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ClinicalTrials.gov Identifier: NCT03004872
Recruitment Status : Active, not recruiting
First Posted : December 29, 2016
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Joanna Kountanis, University of Michigan

Brief Summary:
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.

Condition or disease
Postpartum Period Depression Stress Disorders, Post-Traumatic

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
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Postpartum Mood Disorders and Delivery Experience
Study Start Date : September 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who are planning to give birth at the University of Michigan.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004872


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Joanna Kountanis, MD University of Michigan
Principal Investigator: Elizabeth Langen, MD University of Michigan

Responsible Party: Joanna Kountanis, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03004872     History of Changes
Other Study ID Numbers: HUM00119428
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joanna Kountanis, University of Michigan:
birth experience
postpartum depression
PTSD
pain during labor
pain during cesarean delivery
non-elective induction of labor
unplanned surgery for urgent/emergent cesarean delivery
postpartum hemorrhage

Additional relevant MeSH terms:
Disease
Depression
Mood Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders