Network to Understand Reproductive Rheumatology Registry

NCT06940869 | Enrolling By Invitation

• 1 other identifier: Pro00117179
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the NURTURE Registry is to enroll those who are pregnant and/or potentially capable of pregnancy. Participants will complete patient-reported surveys at enrollment and periodically prior to conception, during pregnancy, and following the completion of the study pregnancy. The study rheumatologist will provide the patient's diagnosis and record rheumatic disease activity at each clinic visit. Medication use, vital signs, and routine laboratory assessments will be collected throughout this period. Pregnancy, maternal, and infant outcomes will be obtained through the electronic medical record and from patient-reported surveys. This Registry will provide a rich data repository for research to improve pregnancy and birth outcomes for women with rheumatic diseases and will be used in on-going and future research to better understand the risk factors that are associated with poor pregnancy outcomes, including preterm birth, intrauterine growth restriction, and preeclampsia, as well as the effects of medication on disease management in pregnancy. Infant outcomes, medications, provider care, pregnancy planning, and social determinants of health on pregnancy and pregnancy outcomes will also be collected. The majority of the information collected in NURTURE, such as labs, disease activity, and medications, PRO's will originate from the EHR. Upon consent, participants will complete an enrollment survey that will include relevant patient reported measures. No study visits outside of routine care will occur. Participants may also complete a yearly survey about their reproductive health journey. The registry will be ongoing and will include periodic analysis of clinical data within this protocol. Additional analysis will be covered under seperate IRB approved protocols. Enrollment in the registry does not significantly increase the risk for a patient.

Conditions

Rheumatic Diseases; Pregnancy Related; Pregnancy Interest; Reproductive Health; Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• Edinburgh post-partum depression scale

  Depression at entry in NURTURE defined by the Edinburgh Postnatal Depression Scale (EPDS) score ≥10 indicating minor depression.

  up to 20 years

Secondary Outcomes (1)

• Readiness for Pregnancy

  up to 20 years

Interventions

NURTURE Registry OTHER

To improve pregnancy and birth outcomes for women with rheumatic diseases and to understand risk factors associated with poor pregnancy outcomes.

Also known as: Women with rheumatic/autoimmune diseases who are pregnant or planning pregnancy

Eligibility Criteria

• Age: 12 Years - 55 Years
• Gender Eligibility Details: Capable of pregnancy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Currently pregnant or desire to become pregnant and have an autoimmune or rheumatic condition.

You may qualify if:

• Diagnosis of an automimmune or rheumatic condition determined by health care provider.
• Age 12-55 who are capable of pregnancy (currently pregnant or planning a pregnancy).
• A patient who receives their care in the Duke Health System.
• Capable of providing informed consent.

You may not qualify if:

• \. Unable to provide informed consent.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Rheumatic Diseases; Autoimmune Diseases

Interventions

Family Planning Services

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Community Health Services; Health Services; Health Care Facilities Workforce and Services; Reproductive Health Services

Study Officials

• Megan Clowse

  Professor of Medicine, Duke University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)