CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 91,084 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02371356
NCT02371356N/ACompleted

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

Kaiser Permanente·observational·Posted Feb 25, 2015·Updated Mar 18, 2020

In Brief

An observational study for Depression and Preterm Delivery. Completed, enrolled 91,084 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2015
Enrollment StartMay 1, 2014
Primary CompletionJan 31, 2017
Study CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.4 years ago