Network to Understand Reproductive Rheumatology Registry (NURTURE)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Autoimmune Diseases; Rheumatic Diseases; Pregnancy Related; Reproductive Health; Pregnancy Interest
• Intervention / Treatment: Other: NURTURE Registry

Detailed Description

The purpose of the NURTURE Registry is to obtain information on those who are pregnant and/or potentially capable of pregnancy. 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.

Participation in NURTURE will be seamless with routine patient care. Any patient with a rheumatic disease seen by a participating site study provider as part routine care, and who could potentially become pregnant (females between the ages of 12 and 55), or who is currently pregnant, will be invited to participate in NURTURE. 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 laboratory assessments will be collected as part of standard clinical care vistis and used in this registry. Pregnancy, maternal, and infant outcomes will be obtained through the electronic medical record and from patient-reported surveys.

Prior to or at each standard of care (non-study, routine) visit, the patient will complete routine clinical questionnaires.

This is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care. Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician.

Enrollment in the registry will not dictate specific therapy.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Unable to provide informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readiness for Pregnancy	We will explore the effect size of the HOP-STEP Intervention on 'personally-ready and 'medically-ready' pregnancies by comparing women who did and did not receive the HOP-STEP Intervention. "Medically ready" will be defined as <1g of proteinuria, no rheumatic teratogens at conception, and continuing pregnancy compatible SLE medications after conception. "Personally ready" will be defined as a planned pregnancy based on a London Measure of Unplanned Pregnancy (LMUP) score ≥10.	up to 20 years

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Megan Clowse, Professor of Medicine, Duke University Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Rheumatic Diseases; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Reproductive Health Services; Family Planning Services
• Other Study ID Numbers: Pro00117179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No