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NCT05852054 · ClinicalTrials.gov registry record · Phase 3

Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)

A Phase 3 study of Gestational Diabetes Mellitus and Hypertension in Pregnancy, sponsored by Northwestern University.

Active
Registry status
Phase 3
Development phase
1,500
Enrollment target
2
Study locations

NCT05852054: Active Phase 3 study of Gestational Diabetes Mellitus and Hypertension in Pregnancy, sponsored by Northwestern University.

NCT05852054 is a Phase 3 study of Gestational Diabetes Mellitus and Hypertension in Pregnancy that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 1,500 participants, above the 325-participant average among 16 other Gestational Diabetes Mellitus trials with a reported enrollment target (362% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05852054, a Phase 3 study of Gestational Diabetes Mellitus and Hypertension in Pregnancy, is active but no longer recruiting, sponsored by Northwestern University.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,500 participants
Enrollment target
2
Study locations

Study Summary

STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).

Primary Outcome

Assess completion of a primary care visit (yes/no) within 6 months of delivery. Using procedures from a pilot study, the investigator will consider an encounter a PCV if it occurred by 6 months after the delivery date; had an assigned provider type of "nurse practitioner," "physician," "internal medicine," "family medicine," and/or "physician assistant;" and did not have an assigned provider type of "OB/GYN" and/or "certified nurse midwife." The PCV rate across STEP-UP vs. UC will be calculated

Interventions

  • BEHAVIORAL Text messaging
  • BEHAVIORAL OB Provider Clinical Decision Support (CDS)
  • BEHAVIORAL Patient Education (OB Visit)
  • BEHAVIORAL Patient Outreach
  • BEHAVIORAL Primary Care Provider Clinical Decision Support (CDS)

Study Locations (2)

Illinois

  • Cook County Health - Chicago
  • AllianceChicago - Chicago

Trial Details

FieldValue
Enrollment Target 1,500 participants
Start Date 2023-11-01
Est. Completion 2026-01-31
Phase Phase 3
Northwestern University

1,209 total trials

What the registry record for NCT05852054 still lists

NCT05852054 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 325-participant average among 16 other Gestational Diabetes Mellitus trials with a reported enrollment target (362% higher).

The record links to 3 conditions, with Gestational Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions - of which Text messaging is the first listed.

NCT05852054 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT05852054 about?

NCT05852054 is a clinical study titled "Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP)". STEP-UP will promote linkage to primary care and ongoing chronic disease evaluation for postpartum women with prior gestational diabetes mellitus (GDM) and/or hypertensive disorders of pregnancy (HDP).

What is the current status of trial NCT05852054?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,500 participants. The study started on 2023-11-01. Estimated completion is 2026-01-31.

What conditions does trial NCT05852054 study?

This clinical trial studies the following conditions: Gestational Diabetes Mellitus, Hypertension in Pregnancy, Dysglycemia.

What interventions are being tested in trial NCT05852054?

The interventions under investigation include: Text messaging (BEHAVIORAL), OB Provider Clinical Decision Support (CDS) (BEHAVIORAL), Patient Education (OB Visit) (BEHAVIORAL), Patient Outreach (BEHAVIORAL), Primary Care Provider Clinical Decision Support (CDS) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05852054?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05852054 being conducted?

This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Gestational Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05852054's enrollment target sits among peer trials

1,500 2nd of 16 the highest of 16 other Gestational Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gestational Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05852054, the US trial registry maintained by the National Library of Medicine. NCT05852054 (large enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.