Relationship Between Postpartum Mood Disorders and Delivery Experience

Depression Clinical Trial

Official title:

Relationship Between Postpartum Mood Disorders and Delivery Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004872
• Other study ID #: HUM00119428
• Status: Completed
• Start date: October 31, 2016
• Est. completion date: December 17, 2018

Study information

• Verified date: February 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Disease
• Mood Disorders
• Postpartum Period
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	1 year postpartum