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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02371356
Acronym
PCORIPTD
Enrollment
91084
Registered
2015-02-25
Start date
2014-05-31
Completion date
2019-04-30
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Preterm Delivery

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

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Kaiser member * Pregnant

Exclusion criteria

* Not a member of Kaiser Permanente * Not pregnant

Design outcomes

Primary

MeasureTime frameDescription
Preterm DeliveryThrough the end of pregnancy, an average of 40 weeksDelivery prior to 37 completed weeks of gestational age
Low Birth WeightThrough the end of pregnancy, an average of 40 weeksBirth weight \<2500 grams

Participant flow

Participants by arm

ArmCount
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
Total91,084

Baseline characteristics

CharacteristicDepressed, UntreatedNot DepressedTotalDepressed, Medication OnlyDepressed, Psychotherapy OnlyDepressed, Medication & Psychotherapy
Age, Customized
Maternal Age
18-24 years
1123 Participants8987 Participants12458 Participants156 Participants1792 Participants400 Participants
Age, Customized
Maternal Age
25-34 years
4440 Participants46148 Participants57080 Participants721 Participants4117 Participants1654 Participants
Age, Customized
Maternal Age
35+ years
1860 Participants17048 Participants21546 Participants443 Participants1445 Participants750 Participants
Race/Ethnicity, Customized
Maternal Race/ethnicity
African-American
577 Participants3773 Participants5598 Participants55 Participants945 Participants248 Participants
Race/Ethnicity, Customized
Maternal Race/ethnicity
Asian
1957 Participants19697 Participants23069 Participants103 Participants1147 Participants165 Participants
Race/Ethnicity, Customized
Maternal Race/ethnicity
Hispanic
2208 Participants18545 Participants23857 Participants283 Participants2200 Participants621 Participants
Race/Ethnicity, Customized
Maternal Race/ethnicity
Other/multiple/unknown
424 Participants3783 Participants4857 Participants66 Participants424 Participants160 Participants
Race/Ethnicity, Customized
Maternal Race/ethnicity
White
2257 Participants26385 Participants33703 Participants813 Participants2638 Participants1610 Participants
Region of Enrollment
United States
7423 Participants72183 Participants91084 Participants1320 Participants7354 Participants2804 Participants
Sex: Female, Male
Female
7423 Participants72183 Participants91084 Participants1320 Participants7354 Participants2804 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
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 / 1,3200 / 7,3540 / 2,8040 / 7,4230 / 72,183
other
Total, other adverse events
0 / 1,3200 / 7,3540 / 2,8040 / 7,4230 / 72,183
serious
Total, serious adverse events
0 / 1,3200 / 7,3540 / 2,8040 / 7,4230 / 72,183

Outcome results

Primary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Depressed, Medication OnlyLow Birth WeightNot low birth weight1226 Participants
Depressed, Medication OnlyLow Birth WeightLow birth weight82 Participants
Depressed, Psychotherapy OnlyLow Birth WeightNot low birth weight6843 Participants
Depressed, Psychotherapy OnlyLow Birth WeightLow birth weight408 Participants
Depressed, Medication & PsychotherapyLow Birth WeightNot low birth weight2620 Participants
Depressed, Medication & PsychotherapyLow Birth WeightLow birth weight158 Participants
Depressed, UntreatedLow Birth WeightLow birth weight385 Participants
Depressed, UntreatedLow Birth WeightNot low birth weight6925 Participants
Not DepressedLow Birth WeightNot low birth weight68919 Participants
Not DepressedLow Birth WeightLow birth weight3154 Participants
Primary

Preterm Delivery

Delivery prior to 37 completed weeks of gestational age

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Depressed, Medication OnlyPreterm DeliveryNot preterm1181 Participants
Depressed, Medication OnlyPreterm DeliveryPreterm139 Participants
Depressed, Psychotherapy OnlyPreterm DeliveryNot preterm6798 Participants
Depressed, Psychotherapy OnlyPreterm DeliveryPreterm556 Participants
Depressed, Medication & PsychotherapyPreterm DeliveryNot preterm2532 Participants
Depressed, Medication & PsychotherapyPreterm DeliveryPreterm272 Participants
Depressed, UntreatedPreterm DeliveryPreterm569 Participants
Depressed, UntreatedPreterm DeliveryNot preterm6854 Participants
Not DepressedPreterm DeliveryPreterm4164 Participants
Not DepressedPreterm DeliveryNot preterm68019 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026