Sponsor study identifier
observational
600
1 country
1
Study Start
October 31, 2016
Actual (reported)Primary Completion
December 17, 2018
Actual (reported)Study Completion
December 17, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 17, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2016
Actual (reported)November 15, 2016
Actual (reported)December 29, 2016
Actual (reported)December 17, 2018
Actual (reported)December 17, 2018
Actual (reported)Association of poor birth experiences with development of postpartum posttraumatic stress disorder (PTSD).
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.
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.
Pregnant women who are planning to give birth at the University of Michigan.
University of Michigan
Ann Arbor, Michigan, 48109, United States
Kountanis JA, Kirk R, Handelzalts JE, Jester JM, Kirk R, Muzik M. The associations of subjective appraisal of birth pain and provider-patient communication with postpartum-onset PTSD. Arch Womens Ment Health. 2022 Feb;25(1):171-180. doi: 10.1007/s00737-021-01154-z. Epub 2021 Jul 12.
Joanna Kountanis, MD
University of Michigan
Elizabeth Langen, MD
University of Michigan
600 participants (actual enrollment reported by the registry).
First Submitted
November 15, 2016
First Posted
December 29, 2016
Study Start
October 31, 2016
Actual (reported)Vilazodone for the Treatment of Posttraumatic Stress Disorder
1 year postpartum
Contact the study team to confirm eligibility.
Primary Completion
December 17, 2018
Actual (reported)Study Completion
December 17, 2018
Actual (reported)Last Updated
February 12, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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