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NCT07460063

Routine vs. Early Postpartum Depression Screening: A Pragmatic Clinical Trial

StatusEnrolling by Invitation
PhaseNot applicable
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrolling by invitation only Show 8 more changesShow less
    • Start date: Sep 2026 to Nov 2026
    • Eligibility criteria expanded, about 8 words
    • Study sites: 0 to 1
    • Primary completion date: Aug 2027 to Sep 2027
    • Study completion date: Jan 2028 to Feb 2028
    • Secondary endpoints: details revised at 9 of 15 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Start date: Jun 2026 to Sep 2026
    • Primary completion pushed from Jun 2027 to Aug 2027
    • Study completion pushed from Dec 2027 to Jan 2028
    v5
  3. Start date: May 2026 to Jun 2026v4
  4. Secondary endpoints: 12 to 15v3
  5. Primary endpoints revised (2)
    • Secondary endpoints revised (12)
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Proportion of positive Edinburgh Postnatal Depression Scale (EPDS) screens at 6 weeks in the routine care group by postpartum depression (PPD) risk status
Timeframe: 6 weeks postpartum is defined as a period between 28-56 days after the day of delivery
Edinburgh Peripartum Depression Scale (EPDS) scores at 2 weeks postpartum in the early screening group by PPD risk status
Timeframe: 2 weeks postpartum is defined as a period between 8-24 days after the day of delivery

Secondary (15)

Edinburgh Postnatal Depression Scale (EPDS) score at 6 weeks in the routine screening group by PPD risk status (high vs. low).
Proportion of individuals with PPD at 6 months postpartum in the routine care group by PPD risk status
Proportion of individuals with PPD at 6 months postpartum in the early screening group by PPD risk status
Proportion of individuals with PPD (excluding EPDS diagnositic criteria) at 6 months postpartum in the routine care group by PPD risk status
Proportion of individuals with PPD (excluding EPDS diagnostic criteria) at 6 months postpartum in the early screening group by PPD risk status
Show 10 moreShow less
Edinburgh Postnatal Depression Scale (EPDS) completion rates at 2 weeks postpartum in the early screening group by PPD risk status
Edinburgh Postnatal Depression Scale (EPDS) completion rates at 6 weeks postpartum in the routine care group by PPD risk status
Proportion of positive Edinburgh Postnatal Depression Scale (EPDS) screens at 2 weeks in the early screening group by PPD risk status
Proportion of positive Edinburgh Postnatal Depression Scale (EPDS) screens at 6 weeks in the early screening group by PPD risk status
Proportion of participants with mental health referrals (social work, therapy, psychology, psychiatry) and treatment (psychotherapy, medication prescription) within 6 months postpartum in the routine care group by PPD risk status
Proportion of participants with mental health referrals (social work, therapy, psychology, psychiatry) and treatment (psychotherapy, medication prescription) within 6 months postpartum in the early screening group by PPD risk status
Days between delivery and first diagnosis of a postpartum mood disorder within 6 months postpartum by PPD risk status
Days between delivery and first mental health referral or treatment within 6 months postpartum in the routine care group by PPD risk status
Days between delivery and first mental health referral or treatment within 6 months postpartum in the early screening group by PPD risk status
Change in Edinburgh Postnatal Depression Scale (EPDS) score between 2 and 6 weeks postpartum in the early screening group by PPD risk status

Arms and interventions

Early Screening among High-Risk ParticipantsExperimental

Early PPD screening among individuals identified at high risk for PPD

Routine Care among High-Risk ParticipantsNo intervention

Routine care among individuals identified at high risk for PPD

Early Screening among Low-Risk ParticipantsExperimental

arly PPD screening among individuals identified at low risk for PPD

Routine Care among Low-Risk ParticipantsNo intervention

Routine care among individuals identified at low risk for PPD

Behavioral: Early PPD Screening

Sites

1 site in 1 country

  • Massachusetts General HospitalBoston, Massachusetts, United States