Network to Understand Reproductive Rheumatology Registry

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06940869
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 55 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
May 2026
Primary completion
Jan 1, 2035
Completion
Jan 1, 2035

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Edinburgh post-partum depression scale [ Time Frame: up to 20 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Medical CenterDurhamNorth Carolina27710-

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By research site
Duke Medical Center· Durham, NC

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