HypertensionNCT05543265

Bridging the Gap From Postpartum to Primary Care

A study testing Default appointment scheduling, Targeted messaging and Nudge Reminders in people with Hypertension and Hypertension in Pregnancy, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Hypertension, Hypertension in Pregnancy, Diabetes Mellitus
What is being tested?: Default appointment scheduling, Targeted messaging and Nudge Reminders
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 siteUnited States
Study dates: 3 Nov 2022to 23 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Estimated date of delivery and the following 4-month postpartum outcome assessment window completed prior to study end date
Currently pregnant or within 2 weeks of delivery
Have one or more of the following conditions: 1) Chronic hypertension, 2) Hypertensive disorders of pregnancy or risk factors for hypertensive disorders of pregnancy per the USPSTF aspirin prescribing guidelines (e.g., history of pre-eclampsia, kidney disease, multiple gestation, autoimmune disease), 3) Type 1 or 2 diabetes, 4) Gestational diabetes, 5) Obesity (pre-pregnancy body mass index ≥30 kg/m2), 6) Depression or anxiety disorder
Have a primary care provider listed in the electronic health record (EHR)
Receive obstetric care at the study institution's outpatient prenatal clinic
Have access to and be enrolled in the EHR patient portal and consents to be contacted via these modalities

Show all 9Show fewer

Able to read/speak English or Spanish language
Age ≥18 years old
Not actively known to have or undergoing work-up for fetal demise

Who cannot join

No primary care provider listed in the EHR
Primary language other than English or Spanish
No access to online patient EHR portal

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women

Chronic health conditions affect most older adults. Preventative medicine and risk management strategies, especially when applied earlier in life, are essential to altering the trajectory of a disease and ultimately improving health outcomes. Primary care providers (PCP) often provide most of these services, though younger adults are the least likely to receive primary care. This project leverages a period of high engagement and health activation during an individual's life (pregnancy) to nudge her toward use of primary care after the pregnancy episode. This randomized controlled trial will test the hypothesis that a behavioral science-informed intervention, incorporating defaults and salience, can increase the rates of PCP follow-up within 4 months following a delivery for individual with hypertension, diabetes, obesity. If successful, this intervention could serve as a scalable solution to increase primary care use and preventative health services in a population that currently has low rates of engagement and utilization of these services.

Read the detailed description

Individuals will be randomized with equal probability into either a treatment or control arm. The intervention combines several features designed to target reasons for low take-up of primary care among postpartum individuals. This project will leverage the potential value of defaults/opt-out, salient information, and reminders to encourage use of primary care. Individuals in both the intervention and control arms will receive information via the study institution's patient portal toward the end of the pregnancy regarding the importance and benefits of primary care in the postpartum year. This information will be similar to, but reinforcing, the information they would receive from their obstetrician about following up with their primary care physician. In addition to this initial message, individuals in the treatment arm will receive the following intervention components, developed based on recent evidence regarding behavioral science approaches to activating health behaviors:

Targeted messages about the importance and benefits of primary care
Default scheduling into a primary care appointment at approximately 3-4 months after delivery
Reminders about the appointment and importance of follow up primary care at 2-4 points during the postpartum period via the patient portal
Tailored language in the reminders based on recent evidence from behavioral science about the most effective approaches to increasing take-up. For example, messages will inform the patient that an appointment is being held for them at their doctor.
Salient labeling on follow-up appointments
Direct PCP messaging about the scheduled follow-up

Conditions: Hypertension, Hypertension in Pregnancy, Diabetes Mellitus, Gestational Diabetes, Obesity, Depressive Disorder
Being tested: Default appointment scheduling, Targeted messaging, Nudge Reminders
Keywords: Postpartum Care, Primary Care, Care Transitions
Medical subject headings: Hypertension, Hypertension, Pregnancy-Induced, Diabetes Mellitus, Diabetes, Gestational, Obesity, Depressive Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Default appointment schedulingBehavioural
Default primary care appointment scheduling
Targeted messagingBehavioural
Patient-specific messages about the importance of postpartum care transition
Nudge RemindersBehavioural
Primary care appointment reminders

Study groups in NCT05543265
Study group	Role	What they receive
Control	No intervention	Routine postpartum care
Facilitated Transition	Experimental	Behavioral science informed interventions to assist in the transition from postpartum to primary care providers Receives: Behavioral: Default appointment scheduling; Behavioral: Targeted messaging; Behavioral: Nudge Reminders

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Primary Care Provider Visit Attendance
Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health)
Measured: 4 months after the patient's estimated date of delivery

Secondary outcomes (27)

Rate of Primary Care Provider Visit Attendance
Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health)
Measured: 12 months after the patient's estimated date of delivery
Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health)
Health care maintenance visit appointment with the patient's assigned primary care provider
Measured: 4 months after the patient's estimated date of delivery
Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health)
Health care maintenance visit appointment with the patient's assigned primary care provider
Measured: 12 months after the patient's estimated date of delivery
Rate of Visit Unscheduled Health Care Visit/Encounter by the Time of Outcome Assessment
Any visit to a urgent care or emergency room visit
Measured: 4 months after the patient's estimated date of delivery
Rate of Visit Unscheduled Health Care Visit/Encounter
Any visit to a urgent care or emergency room visit
Measured: 12 months after the patient's estimated date of delivery
Rate of Contraception Plan Documented by the Time of Outcome Assessment
Contraception plan documented by any provider after delivery
Measured: 4 months after the patient's estimated date of delivery
Rate of Long-acting Contraception Use at Time of Outcome Assessment
Long-acting contraception use (implant, intrauterine device)
Measured: 4 months after the patient's estimated date of delivery
Rate of Long-acting Contraception Use
Long-acting contraception use (implant, intrauterine device)
Measured: 12 months after the patient's estimated date of delivery
Rate of Contraception Plan Documented
Contraception plan documented by any provider after delivery
Measured: 12 months after the patient's estimated date of delivery
Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes
Postpartum diabetes screening among those diagnosed with gestational diabetes
Measured: 4 months after the patient's estimated date of delivery
Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes
Postpartum diabetes screening among those diagnosed with gestational diabetes
Measured: 12 months after the patient's estimated date of delivery
Rate of Weight Counseling Documented in the Health Record Among Those With Obesity
Weight counseling documentation among those with obesity
Measured: 4 months after the patient's estimated date of delivery
Rate of Weight Counseling Documented in the Health Record Among Those With Obesity
Weight counseling documentation among those with obesity
Measured: 12 months after the patient's estimated date of delivery
Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension
Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension
Measured: 4 months after the patient's estimated date of delivery
Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension
Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension
Measured: 12 months after the patient's estimated date of delivery
Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders
Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders
Measured: 4 months after the patient's estimated date of delivery
Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders
Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders
Measured: 12 months after the patient's estimated date of delivery
Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders
New or continued antidepressant prescription use
Measured: 4 months after the patient's estimated date of delivery
Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders
New or continued antidepressant prescription use
Measured: 12 months after the patient's estimated date of delivery
Rate of Antihypertensive Use Among Individuals With Hypertension
New or continued antihypertensive medication use among individuals with hypertension
Measured: 4 months after the patient's estimated date of delivery
Rate of Antihypertensive Use Among Individuals With Hypertension
New or continued antihypertensive medication use among individuals with hypertension
Measured: 12 months after the patient's estimated date of delivery
Rate of Medication Use for Glycemic Control Among Individuals With Diabetes
New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes
Measured: 4 months after the patient's estimated date of delivery
Rate of Medication Use for Glycemic Control Among Individuals With Diabetes
New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes
Measured: 12 months after the patient's estimated date of delivery
Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes
Laboratory glucose screening test among individuals with or at risk for diabetes
Measured: 4 months after the patient's estimated date of delivery
Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes
Laboratory glucose screening test among individuals with or at risk for diabetes
Measured: 12 months after the patient's estimated date of delivery
Rate of Patient-reported Primary Care Visit Attendance
Primary care provider visit attendance per patient report
Measured: 4 months after the patient's estimated date of delivery
Rate of Patient-reported Primary Care Visit Attendance
Primary care provider visit attendance per patient report
Measured: 12 months after the patient's estimated date of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202223 Jul 2024

First posted16 Sep 2022
Study start3 Nov 2022
Primary completion11 Oct 2023
Study completion23 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05543265
Sponsor's protocol ID: 2022P001723
Other IDs: P30AG034532, P30AG064190
Status last verified: Sep 2024
First submitted: 6 Sep 2022
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Eddelbuettel JCP, Ray A, Liang P, James KE, Ganguli I, Clapp MA, Cohen JL. Facilitated Transitions to Postpartum Primary Care and Mental Health Care Services: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2630415. doi: 10.1001/jamanetworkopen.2026.30415.
PubMed 42640640
Gangaram A, Ganguli I, Ray A, Liang P, Bald C, Clapp MA, Cohen JL. Postpartum Primary Care Engagement and Acute Care Use: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610798. doi: 10.1001/jamanetworkopen.2026.10798.
PubMed 42090155
Delgado A, Liang P, Bender T, Ray A, James KE, Ganguli I, Cohen JL, Clapp MA. Primary Care Utilization Within 1 Year After a Facilitated Postpartum-to-Primary Care Transition. Obstet Gynecol. 2025 Apr 1;145(4):409-416. doi: 10.1097/AOG.0000000000005848. Epub 2025 Feb 13.
PubMed 40117132
Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen JL. Postpartum Primary Care Engagement Using Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422500. doi: 10.1001/jamanetworkopen.2024.22500.
PubMed 39012630
Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen J. Increasing Postpartum Primary Care Engagement through Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. medRxiv [Preprint]. 2024 May 1:2024.01.21.24301585. doi: 10.1101/2024.01.21.24301585.
PubMed 38633772

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women
ClinicalTrials.gov ID: NCT05543265
Acronym / sponsor ID: 2022P001723
Conditions: Hypertension, Hypertension in Pregnancy, Diabetes Mellitus, Gestational Diabetes, Obesity, Depressive Disorder
Keywords: Postpartum Care, Primary Care, Care Transitions
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), National Bureau of Economic Research, Inc., Massachusetts Institute of Technology
Study start: 3 Nov 2022 (actual)
Primary completion: 11 Oct 2023 (actual)
Study completion: 23 Jul 2024 (actual)
First posted: 16 Sep 2022 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Targeted messages about the importance and benefits of primary care
Default scheduling into a primary care appointment at approximately 3-4 months after delivery
Reminders about the appointment and importance of follow up primary care at 2-4 points during the postpartum period via the patient portal
Tailored language in the reminders based on recent evidence from behavioral science about the most effective approaches to increasing take-up. For example, messages will inform the patient that an appointment is being held for them at their doctor.
Salient labeling on follow-up appointments
Direct PCP messaging about the scheduled follow-up

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Routine postpartum care
Facilitated Transition	Experimental	Behavioral: Default appointment scheduling, Behavioral: Targeted messaging, Behavioral: Nudge RemindersBehavioral science informed interventions to assist in the transition from postpartum to primary care providers

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Estimated date of delivery and the following 4-month postpartum outcome assessment window completed prior to study end date
Currently pregnant or within 2 weeks of delivery
Have one or more of the following conditions: 1) Chronic hypertension, 2) Hypertensive disorders of pregnancy or risk factors for hypertensive disorders of pregnancy per the USPSTF aspirin prescribing guidelines (e.g., history of pre-eclampsia, kidney disease, multiple gestation, autoimmune disease), 3) Type 1 or 2 diabetes, 4) Gestational diabetes, 5) Obesity (pre-pregnancy body mass index ≥30 kg/m2), 6) Depression or anxiety disorder
Have a primary care provider listed in the electronic health record (EHR)
Receive obstetric care at the study institution's outpatient prenatal clinic

Key exclusion criteria (3 listed)

No primary care provider listed in the EHR
Primary language other than English or Spanish
No access to online patient EHR portal

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Default appointment schedulingDefault primary care appointment scheduling	Behavioural	Facilitated Transition
Targeted messagingPatient-specific messages about the importance of postpartum care transition	Behavioural	Facilitated Transition
Nudge RemindersPrimary care appointment reminders	Behavioural	Facilitated Transition

Primary outcome

Rate of Primary Care Provider Visit Attendance
Time frame: 4 months after the patient's estimated date of delivery
Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health)

27 secondary outcomes

Rate of Primary Care Provider Visit Attendance
Time frame: 12 months after the patient's estimated date of delivery
Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health)
Time frame: 4 months after the patient's estimated date of delivery
Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health)
Time frame: 12 months after the patient's estimated date of delivery
Rate of Visit Unscheduled Health Care Visit/Encounter by the Time of Outcome Assessment
Time frame: 4 months after the patient's estimated date of delivery
Rate of Visit Unscheduled Health Care Visit/Encounter
Time frame: 12 months after the patient's estimated date of delivery
Rate of Contraception Plan Documented by the Time of Outcome Assessment
Time frame: 4 months after the patient's estimated date of delivery
Rate of Long-acting Contraception Use at Time of Outcome Assessment
Time frame: 4 months after the patient's estimated date of delivery
Rate of Long-acting Contraception Use
Time frame: 12 months after the patient's estimated date of delivery
Rate of Contraception Plan Documented
Time frame: 12 months after the patient's estimated date of delivery
Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes
Time frame: 4 months after the patient's estimated date of delivery
Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes
Time frame: 12 months after the patient's estimated date of delivery
Rate of Weight Counseling Documented in the Health Record Among Those With Obesity
Time frame: 4 months after the patient's estimated date of delivery
Rate of Weight Counseling Documented in the Health Record Among Those With Obesity
Time frame: 12 months after the patient's estimated date of delivery
Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension
Time frame: 4 months after the patient's estimated date of delivery
Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension
Time frame: 12 months after the patient's estimated date of delivery
Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders
Time frame: 4 months after the patient's estimated date of delivery
Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders
Time frame: 12 months after the patient's estimated date of delivery
Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders
Time frame: 4 months after the patient's estimated date of delivery
Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders
Time frame: 12 months after the patient's estimated date of delivery
Rate of Antihypertensive Use Among Individuals With Hypertension
Time frame: 4 months after the patient's estimated date of delivery
Rate of Antihypertensive Use Among Individuals With Hypertension
Time frame: 12 months after the patient's estimated date of delivery
Rate of Medication Use for Glycemic Control Among Individuals With Diabetes
Time frame: 4 months after the patient's estimated date of delivery
Rate of Medication Use for Glycemic Control Among Individuals With Diabetes
Time frame: 12 months after the patient's estimated date of delivery
Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes
Time frame: 4 months after the patient's estimated date of delivery
Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes
Time frame: 12 months after the patient's estimated date of delivery
Rate of Patient-reported Primary Care Visit Attendance
Time frame: 4 months after the patient's estimated date of delivery
Rate of Patient-reported Primary Care Visit Attendance
Time frame: 12 months after the patient's estimated date of delivery

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	176	173
Facilitated Transition	184	180

Primary outcome: Rate of Primary Care Provider Visit Attendance

Time frame: 4 months after the patient's estimated date of delivery. Count of participants. Unit: Participants

Measure	Control n = 173	Facilitated Transition n = 180
Value	38	72

Control vs Facilitated Transition: Mean Difference (Final Values): 22.0 (95% CI 6.4 to 28.8), p <0.001, Chi-squared

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 173 (0%)	0 of 173 (0%)	0 of 173
Facilitated Transition	0 of 180 (0%)	0 of 180 (0%)	0 of 180

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42640640Eddelbuettel JCP, Ray A, Liang P, James KE, Ganguli I, Clapp MA, Cohen JL. Facilitated Transitions to Postpartum Primary Care and Mental Health Care Services: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2630415. doi: 10.1001/jamanetworkopen.2026.30415.
Derived from this study: PubMed 42090155Gangaram A, Ganguli I, Ray A, Liang P, Bald C, Clapp MA, Cohen JL. Postpartum Primary Care Engagement and Acute Care Use: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610798. doi: 10.1001/jamanetworkopen.2026.10798.
Derived from this study: PubMed 40117132Delgado A, Liang P, Bender T, Ray A, James KE, Ganguli I, Cohen JL, Clapp MA. Primary Care Utilization Within 1 Year After a Facilitated Postpartum-to-Primary Care Transition. Obstet Gynecol. 2025 Apr 1;145(4):409-416. doi: 10.1097/AOG.0000000000005848. Epub 2025 Feb 13.
Derived from this study: PubMed 39012630Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen JL. Postpartum Primary Care Engagement Using Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422500. doi: 10.1001/jamanetworkopen.2024.22500.
Derived from this study: PubMed 38633772Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen J. Increasing Postpartum Primary Care Engagement through Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. medRxiv [Preprint]. 2024 May 1:2024.01.21.24301585. doi: 10.1101/2024.01.21.24301585.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark A Clapp, MD, MPH principal investigator

Massachusetts General Hospital

Jessica L Cohen, PhD principal investigator

Harvard School of Public Health (HSPH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Primary Care Provider Visit Attendance (time frame: 4 months after the patient's estimated date of delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05543265, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.