Recruiting

Postpartum Care

Sponsor:

Massachusetts General Hospital

Code:

NCT06557005

Conditions

Hypertension

Diabetes

Postpartum

Pregnancy

Anxiety

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Facilitated Transition to Primary Care

Study Details

Brief summary:

The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the >30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.

Conditions

Hypertension

Diabetes

Postpartum

Pregnancy

Anxiety

Study ID

NCT06557005

Start date

May 23, 2025

Status verified date

Jul, 2026

Completion date

May 23, 2028

Anticipated

Primary completion date

May 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)
  • Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age
  • If postpartum, has a neonate that is currently living at the time of enrollment
  • Has one or more of the following conditions listed in the "Problem List," "Medical History," or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):

  • Chronic or essential hypertension
  • Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)
  • Type 1 or 2 diabetes (i.e., pre-existing diabetes)
  • Gestational diabetes
  • Class II Obesity (pre-pregnancy body mass index ≥35 kg/m2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg/m2)
  • Depression or anxiety disorder
  • Has a primary care clinician listed in the patient's medical record
  • Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities
  • Able to read/speak English or Spanish language
  • Is age ≥18 years old

Exclusion Criteria

• Any individual not meeting all inclusion criteria

Study Design

Enrollment

1320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Routine Care

Routine postpartum care

active comparator: Facilitated Transition Group

The intervention is integrated into routine inpatient postpartum care and includes the following components: default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient.

Interventions

Facilitated Transition to Primary Care

The intervention includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient.

Primary outcome measure

  • Completion of a primary care visit [ Time Frame: 155 days after date of delivery ]
  • Receipt of condition-specific recommended health screening and counseling by a primary care practitioner [ Time Frame: 155 days after date of delivery ]
  • Self-report of having a known, reliable primary care practitioner [ Time Frame: 155 days after date of delivery ]
  • Self-report of mental health [ Time Frame: 155 days after date of delivery ]

Central Contacts and Locations

Central contacts

Mark A Clapp, MD, MPH

617-726-2000mark.clapp@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Postpartum Care
  • Primary Care
  • Care Transitions
  • Chronic Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-13.