Routine vs. Early Postpartum Depression Screening: A Pragmatic Clinical Trial (NCT07460063) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Routine vs. Early Postpartum Depression Screening: A Pragmatic Clinical Trial
428 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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\*
. Age ≥18 years old
Exclusion criteria
. A diagnosis code in the EHR for major depressive disorder, bipolar disorder, or psychotic disorder within the year prior to delivery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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