Relationship Between Postpartum Mood Disorders and Delivery Experience

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT03004872

Collaborator

(none)

600

Enrollment

Location

25.5

Actual Duration (Months)

23.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Relationship Between Postpartum Mood Disorders and Delivery Experience

Actual Study Start Date :

Oct 31, 2016

Actual Primary Completion Date :

Dec 17, 2018

Actual Study Completion Date :

Dec 17, 2018

Outcome Measures

Primary Outcome Measures

Association of poor birth experiences with development of postpartum posttraumatic stress disorder (PTSD). [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.
Association of poor birth experience with development of postpartum depression. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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