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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital

About this trial

After having a baby, some women develop a condition called postpartum depression, or PPD, which can cause sadness, anxiety, and difficulty bonding with their newborn. Right now, most women aren't screened for PPD until about 6 to 8 weeks after giving birth, but this study wants to find out if checking earlier could help identify signs sooner. To test this, researchers will work with 428 women who deliver at an MGH hospital clinic and have no history of depression. Each woman will be randomly placed into one of two groups: one group will fill out a short depression questionnaire online at 2 to 3 weeks after delivery, while the other group will follow the usual process and complete the same questionnaire at their regular 6-week visit. The results will go to each woman's doctor, who will decide if any follow-up care is needed, just like they normally would. The study will follow each participant for 6 months after delivery to see whether earlier screening makes a difference.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Live birth, term (≥37 weeks) delivery at Massachusetts General Hospital

Access to Patient Gateway, as to receive the electronic EPDS scale

Primary obstetric provider at MGH or its affiliated clinics

No recent history of depressive disorder as determined through diagnoses or medication use*

Disqualifiers

A diagnosis code in the EHR for major depressive disorder, bipolar disorder, or psychotic disorder within the year prior to delivery

Antidepressant, antipsychotic, or bipolar medication use within the year prior to delivery

Age <18 years old

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early PPD Screening

    Behavioral

    Edinburgh Perinatal Depression Scale (EPDS) administered at approximately 2 weeks postpartum

Treatment groups

428 Participants
are divided into 4 treatment groups
Group A: Early Screening among High-Risk ParticipantsExperimental treatment 1 intervention
Group B: Routine Care among High-Risk ParticipantsNo intervention 0 interventions
Group C: Early Screening among Low-Risk ParticipantsExperimental treatment 1 intervention
Group D: Routine Care among Low-Risk ParticipantsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of positive Edinburgh Postnatal Depression Scale (EPDS) screens at 6 weeks in the routine care group by postpartum depression (PPD) risk status

To compare rates of positive EPDS screens (EPDS \>12) at 6 weeks (in the routine care group) by PPD risk status (high vs. low)

Time frame
6 weeks postpartum is defined as a period between 28-56 days after the day of delivery
2

Edinburgh Peripartum Depression Scale (EPDS) scores at 2 weeks postpartum in the early screening group by PPD risk status

To compare EPDS scores at 2 weeks postpartum by PPD risk status (high vs. low) in the early screening group. EPDS score: range 0-30; higher scores are more strongly associated with PPD

Time frame
2 weeks postpartum is defined as a period between 8-24 days after the day of delivery

Secondary outcomes

1

Edinburgh Postnatal Depression Scale (EPDS) score at 6 weeks in the routine screening group by PPD risk status (high vs. low).

To compare EPDS scores at 6 weeks postpartum among women at high and low risk in the standard screening group. EPDS score: range 0-30; higher scores are more strongly associated with PPD

Time frame
6 weeks postpartum is defined as a period between 28-56 days after the day of delivery
2

Proportion of individuals with PPD at 6 months postpartum in the routine care group by PPD risk status

To compare the incidence of PPD (as defined by the presence of a diagnosis code for a mood or depressive disorder, a psychiatric medication prescription, or EPDS results \>12) at 6 months postpartum by PPD risk status (high vs. low) in the routine care group

Time frame
6 months postpartum is defined as a period between the day of delivery and 180 days after delivery
3

Proportion of individuals with PPD at 6 months postpartum in the early screening group by PPD risk status

To compare the incidence of PPD (as defined by the presence of a diagnosis code for a mood or depressive disorder, a psychiatric medication prescription, or EPDS results \>12) at 6 months postpartum by PPD risk status (high vs. low) in the early screening group

Time frame
6 months postpartum is defined as a period between the day of delivery and 180 days after delivery
4

Proportion of individuals with PPD (excluding EPDS diagnositic criteria) at 6 months postpartum in the routine care group by PPD risk status

To compare the incidence of PPD (as defined by the presence of a diagnosis code for a mood or depressive disorder, or a psychiatric medication prescription, but not an EPDS results \>12) at 6 months postpartum by PPD risk status (high vs. low) in the routine care group

Time frame
6 months postpartum is defined as a period between the day of delivery and 180 days after delivery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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