Depression, Preterm Delivery
Conditions
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Kaiser member * Pregnant
Exclusion criteria
* Not a member of Kaiser Permanente * Not pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm Delivery | Through the end of pregnancy, an average of 40 weeks | Delivery prior to 37 completed weeks of gestational age |
| Low Birth Weight | Through the end of pregnancy, an average of 40 weeks | Birth weight \<2500 grams |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Depressed, Medication Only Screen positive for depression and use only antidepressants during pregnancy | 1,320 |
| Depressed, Psychotherapy Only Screen positive for depression and receive psychotherapy only | 7,354 |
| Depressed, Medication & Psychotherapy Screen positive for depression and receive both antidepressants and psychotherapy | 2,804 |
| Depressed, Untreated Screen positive for depression and receive no treatment | 7,423 |
| Not Depressed Screen negative for depression and received no treatment | 72,183 |
| Total | 91,084 |
Baseline characteristics
| Characteristic | Depressed, Untreated | Not Depressed | Total | Depressed, Medication Only | Depressed, Psychotherapy Only | Depressed, Medication & Psychotherapy |
|---|---|---|---|---|---|---|
| Age, Customized Maternal Age 18-24 years | 1123 Participants | 8987 Participants | 12458 Participants | 156 Participants | 1792 Participants | 400 Participants |
| Age, Customized Maternal Age 25-34 years | 4440 Participants | 46148 Participants | 57080 Participants | 721 Participants | 4117 Participants | 1654 Participants |
| Age, Customized Maternal Age 35+ years | 1860 Participants | 17048 Participants | 21546 Participants | 443 Participants | 1445 Participants | 750 Participants |
| Race/Ethnicity, Customized Maternal Race/ethnicity African-American | 577 Participants | 3773 Participants | 5598 Participants | 55 Participants | 945 Participants | 248 Participants |
| Race/Ethnicity, Customized Maternal Race/ethnicity Asian | 1957 Participants | 19697 Participants | 23069 Participants | 103 Participants | 1147 Participants | 165 Participants |
| Race/Ethnicity, Customized Maternal Race/ethnicity Hispanic | 2208 Participants | 18545 Participants | 23857 Participants | 283 Participants | 2200 Participants | 621 Participants |
| Race/Ethnicity, Customized Maternal Race/ethnicity Other/multiple/unknown | 424 Participants | 3783 Participants | 4857 Participants | 66 Participants | 424 Participants | 160 Participants |
| Race/Ethnicity, Customized Maternal Race/ethnicity White | 2257 Participants | 26385 Participants | 33703 Participants | 813 Participants | 2638 Participants | 1610 Participants |
| Region of Enrollment United States | 7423 Participants | 72183 Participants | 91084 Participants | 1320 Participants | 7354 Participants | 2804 Participants |
| Sex: Female, Male Female | 7423 Participants | 72183 Participants | 91084 Participants | 1320 Participants | 7354 Participants | 2804 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,320 | 0 / 7,354 | 0 / 2,804 | 0 / 7,423 | 0 / 72,183 |
| other Total, other adverse events | 0 / 1,320 | 0 / 7,354 | 0 / 2,804 | 0 / 7,423 | 0 / 72,183 |
| serious Total, serious adverse events | 0 / 1,320 | 0 / 7,354 | 0 / 2,804 | 0 / 7,423 | 0 / 72,183 |
Outcome results
Low Birth Weight
Birth weight \<2500 grams
Time frame: Through the end of pregnancy, an average of 40 weeks
Population: Those with missing birth weight information were excluded from the analysis of low birth weight
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Depressed, Medication Only | Low Birth Weight | Not low birth weight | 1226 Participants |
| Depressed, Medication Only | Low Birth Weight | Low birth weight | 82 Participants |
| Depressed, Psychotherapy Only | Low Birth Weight | Not low birth weight | 6843 Participants |
| Depressed, Psychotherapy Only | Low Birth Weight | Low birth weight | 408 Participants |
| Depressed, Medication & Psychotherapy | Low Birth Weight | Not low birth weight | 2620 Participants |
| Depressed, Medication & Psychotherapy | Low Birth Weight | Low birth weight | 158 Participants |
| Depressed, Untreated | Low Birth Weight | Low birth weight | 385 Participants |
| Depressed, Untreated | Low Birth Weight | Not low birth weight | 6925 Participants |
| Not Depressed | Low Birth Weight | Not low birth weight | 68919 Participants |
| Not Depressed | Low Birth Weight | Low birth weight | 3154 Participants |
Preterm Delivery
Delivery prior to 37 completed weeks of gestational age
Time frame: Through the end of pregnancy, an average of 40 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Depressed, Medication Only | Preterm Delivery | Not preterm | 1181 Participants |
| Depressed, Medication Only | Preterm Delivery | Preterm | 139 Participants |
| Depressed, Psychotherapy Only | Preterm Delivery | Not preterm | 6798 Participants |
| Depressed, Psychotherapy Only | Preterm Delivery | Preterm | 556 Participants |
| Depressed, Medication & Psychotherapy | Preterm Delivery | Not preterm | 2532 Participants |
| Depressed, Medication & Psychotherapy | Preterm Delivery | Preterm | 272 Participants |
| Depressed, Untreated | Preterm Delivery | Preterm | 569 Participants |
| Depressed, Untreated | Preterm Delivery | Not preterm | 6854 Participants |
| Not Depressed | Preterm Delivery | Preterm | 4164 Participants |
| Not Depressed | Preterm Delivery | Not preterm | 68019 Participants |