Clinical trial NCT03004872: Relationship Between Postpartum Mood Disorders and Delivery Experience
Official title: Relationship Between Postpartum Mood Disorders and Delivery Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Period
Depression
Stress Disorders, Post-Traumatic
Keywords: 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
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are planning to give birth at the 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.

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.

Eligibility 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

Primary outcomes:
measure: Association of poor birth experiences with development of postpartum posttraumatic stress disorder (PTSD).
timeFrame: 1 year postpartum
measure: Association of poor birth experience with development of postpartum depression.
timeFrame: 1 year postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Joanna Kountanis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Elizabeth Langen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.