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- Klinische proef NCT02371356
Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health (PCORIPTD)
12 maart 2020 bijgewerkt door: Kaiser Permanente
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
91084
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Pregnant KPNC members who have been screened as part of KPNC's peripartum depression screening program, assigned to cohorts according to depression and treatment status.
Beschrijving
Inclusion Criteria:
- Kaiser member
- Pregnant
Exclusion Criteria:
- Not a member of Kaiser Permanente
- Not pregnant
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
---|
Depressed, Medication only
Screen positive for depression and use only antidepressants during pregnancy
|
Depressed, Psychotherapy only
Screen positive for depression and receive psychotherapy only.
|
Depressed, Medication & Psychotherapy
Screen positive for depression and receive both antidepressants and psychotherapy.
|
Depressed, untreated
Screen positive for depression and receive no treatment.
|
Not depressed
Screen negative for depression and receive no treatment.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Preterm Delivery
Tijdsspanne: Through the end of pregnancy, an average of 40 weeks
|
Delivery prior to 37 completed weeks of gestational age
|
Through the end of pregnancy, an average of 40 weeks
|
Low Birth Weight
Tijdsspanne: Through the end of pregnancy, an average of 40 weeks
|
Birth weight <2500 grams
|
Through the end of pregnancy, an average of 40 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2014
Primaire voltooiing (Werkelijk)
31 januari 2017
Studie voltooiing (Werkelijk)
30 april 2019
Studieregistratiedata
Eerst ingediend
28 januari 2015
Eerst ingediend dat voldeed aan de QC-criteria
24 februari 2015
Eerst geplaatst (Schatting)
25 februari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
12 maart 2020
Laatst geverifieerd
1 maart 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CN-13-1650-H
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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