Rheumatic DiseasesNURTURENCT06940869
Network to Understand Reproductive Rheumatology Registry
An observational study of Rheumatic Diseases and Pregnancy Related, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 55 years, women only
- Conditions the study is for
- Rheumatic Diseases, Pregnancy Related, Pregnancy Interest
- What is being tested?
- NURTURE Registry
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 1 Jan 2035
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Currently pregnant or desire to become pregnant and have an autoimmune or rheumatic condition.
Who may be able to join
- 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.
Who cannot join
- 1. Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Rheumatic Diseases, Pregnancy Related, Pregnancy Interest, Reproductive Health, Autoimmune Diseases
- Being tested
- NURTURE Registry
- Medical subject headings
- Rheumatic Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NURTURE RegistryOther
Also called Women with rheumatic/autoimmune diseases who are pregnant or planning pregnancy
To improve pregnancy and birth outcomes for women with rheumatic diseases and to understand risk factors associated with poor pregnancy outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh post-partum depression scale
Depression at entry in NURTURE defined by the Edinburgh Postnatal Depression Scale (EPDS) score ≥10 indicating minor depression.
Measured: up to 20 years
Secondary outcomes (1)
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.
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start19 May 2025
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Clowse, Principal investigator, Professor of Medicine, Duke University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940869
- Sponsor's protocol ID
- Pro00117179
- Acronym
- NURTURE
- Status last verified
- May 2026
- First submitted
- 16 Apr 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network to Understand Reproductive Rheumatology Registry
- ClinicalTrials.gov ID
- NCT06940869
- Acronym / sponsor ID
- NURTURE / Pro00117179
- Conditions
- Rheumatic Diseases, Pregnancy Related, Pregnancy Interest, Reproductive Health, Autoimmune Diseases
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Currently pregnant or desire to become pregnant and have an autoimmune or rheumatic condition.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NURTURE RegistryAlso: Women with rheumatic/autoimmune diseases who are pregnant or planning pregnancyTo improve pregnancy and birth outcomes for women with rheumatic diseases and to understand risk factors associated with poor pregnancy outcomes. | Other | – |
Primary outcome
Edinburgh post-partum depression scale
Time frame: up to 20 years
Depression at entry in NURTURE defined by the Edinburgh Postnatal Depression Scale (EPDS) score ≥10 indicating minor depression.
1 secondary outcome
Readiness for Pregnancy
Time frame: up to 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Clowse principal investigator
Professor of Medicine, Duke University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases and Pregnancy Related, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh post-partum depression scale (time frame: up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.