N/A
N=91,084
Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health
Depression · Preterm Delivery
Bottom Line
View on ClinicalTrials.gov: NCT02371356 ↗Enrolled (actual)
91,084
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Preterm Delivery — 139; 556; 272; 569 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preterm Delivery |
139; 556; 272; 569; 4164; 1181 | — |
| PRIMARY Low Birth Weight |
82; 408; 158; 385; 3154; 1226 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Kaiser member
- Pregnant
Exclusion Criteria
- Not a member of Kaiser Permanente
- Not pregnant
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.