Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health

NCT02371356 | Completed Results

• 1 other identifier: CN-13-1650-H
• Study Type: observational
• Target: 91,084
• Locations: 0 countries
• Sites: N/A

Brief Summary

Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments. We propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination. The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups. Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.

Conditions

Depression; Preterm Delivery

Outcome Measures

Primary Outcomes (2)

• Preterm Delivery

  Delivery prior to 37 completed weeks of gestational age

  Through the end of pregnancy, an average of 40 weeks

• Low Birth Weight

  Birth weight \<2500 grams

  Through the end of pregnancy, an average of 40 weeks

Study Arms (5)

Depressed, Medication only

Screen positive for depression and use only antidepressants during pregnancy

Depressed, Psychotherapy only

Screen positive for depression and receive psychotherapy only.

Depressed, Medication & Psychotherapy

Screen positive for depression and receive both antidepressants and psychotherapy.

Depressed, untreated

Screen positive for depression and receive no treatment.

Not depressed

Screen negative for depression and receive no treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant KPNC members who have been screened as part of KPNC's peripartum depression screening program, assigned to cohorts according to depression and treatment status.

You may qualify if:

• Kaiser member
• Pregnant

You may not qualify if:

• Not a member of Kaiser Permanente
• Not pregnant

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Depression; Premature Birth

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: De-Kun Li, MD, PhD
• Organization: Kaiser Permanente Division of Research

De-Kun.Li@kp.org

510.891.3749

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 25, 2015
• Study Start: May 1, 2014
• Primary Completion: January 31, 2017
• Study Completion: April 30, 2019
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share