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Clinical Trials/NCT02371356
NCT02371356
Completed
Not Applicable

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

Kaiser Permanente0 sites91,084 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Kaiser Permanente
Enrollment
91084
Primary Endpoint
Preterm Delivery
Status
Completed
Last Updated
6 years ago

Overview

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.

Detailed Description

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. Kaiser Permanente Northern California has implemented a large scale universal peripartum depression screening program, annually screening more than 35,000 pregnant women. Taking advantage of this unique infrastructure, 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. Stakeholders (patients, advocacy groups, and providers) are an integral part of the research team. Four cohorts with different treatment options including untreated will be formed within each depression type (with or without comorbidity): (A) "Antidepressant only": screen positive for depression and use only antidepressants during pregnancy; (B) "Psychotherapy only": screen positive and receive psychotherapy only; (C) "Combination therapy": screen positive and receive both antidepressants and psychotherapy; (D)"Untreated depression": screen positive and receive no treatment. A total of eight cohorts will be formed. A final cohort (E) "No depression": screen negative and receive no treatment, will be examined for baseline comparison. Information on depression treatment and PTD and LBW will be available for all participating women who will be followed until the end of pregnancy. Within each depression category, comparison of Cohort A, B \& C to D, respectively, will determine if treating depression is effective. Pair-wise comparisons among Cohorts A, B \& C will determine the comparative effectiveness of treatment regimens. Comparison of Cohort D to E provides baseline fetal risks of untreated depression. 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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
April 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Kaiser member

Exclusion Criteria

  • Not a member of Kaiser Permanente
  • Not pregnant

Outcomes

Primary Outcomes

Preterm Delivery

Time Frame: Through the end of pregnancy, an average of 40 weeks

Delivery prior to 37 completed weeks of gestational age

Low Birth Weight

Time Frame: Through the end of pregnancy, an average of 40 weeks

Birth weight \<2500 grams

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