Maternal Health Assessment in Pediatric Care

NCT07294573 | Enrolling By Invitation

• 2 other identifiers: STU002243921001PC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The major goal of this study is to develop and pilot M-HARP (Maternal Health Assessment and Referral Integrated into Pediatric Care). M-HARP will adapt a successful US-based health screening and referral protocol to fit the needs of new mothers at Clínica de Familia La Romana, Dominican Republic.

Conditions

Postpartum Care; Primary Care; Mental Health; Family Planning; Care Coordination

Outcome Measures

Primary Outcomes (1)

• Adoption

  Adoption will be measured by the percentage of pediatricians that document review of questionnaire along with the percentage of women that complete the entire questionnaire once enrolled

  From enrollment to one week after enrollment

Secondary Outcomes (4)

• Effectiveness

  from enrollment until 6 months from enrollment

• Reach

  from enrollment until completion of baseline questionnaire

• Implementation

  from enrollment to 6 months after enrollment

• Maintenance

  from enrollment to 6 months following enrollment

Study Arms (2)

Standard of Care

NO INTERVENTION

M-HARP recipient

EXPERIMENTAL

Participants will complete a brief health questionnaire and will be referred to clinical care if indicated.

Behavioral: referral

Interventions

referral BEHAVIORAL

Participants in the intervention arm will be given the "M-HARP questionnaire." The M-HARP questionnaire will gather information on healthcare visits since delivery, desire for contraception, depression screening, and desire for referral. The M-HARP questionnaire will be subsequently reviewed by the pediatrician. If the participants meet the criteria, they will be referred to the appropriate clinical service, including primary care, obstetrics and gynecology, family planning and psychological care.

M-HARP recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women attending pediatric visits at Clínica de Familia La Romana during the study period
• Women in postpartum period, with children up to 6 months of age ≥18 years

You may not qualify if:

• Pregnant with another child, since they will be triaged to prenatal care rather than postpartum primary care
• Unwilling and unable to consent
• Women who do not speak Spanish or Creole.

Sponsors & Collaborators

• John James Parker: lead
• Clínica de Familia La Romana, Dominican Republic: collaborator

Study Sites (1)

Clínica De Familia

La Romana, Dominican Republic

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: November 17, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)