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N/A Completed N=91,084

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

Source: ClinicalTrials.gov NCT02371356 ↗
Enrolled (actual)
91,084
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Preterm Delivery — 139; 556; 272; 569 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Preterm Delivery
139; 556; 272; 569; 4164; 1181
PRIMARY
Low Birth Weight
82; 408; 158; 385; 3154; 1226

Eligibility Criteria

Inclusion Criteria

  • Kaiser member
  • Pregnant

Exclusion Criteria

  • Not a member of Kaiser Permanente
  • Not pregnant
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02371356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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