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The Effect of Sulfasalazine on CRH Levels in Pregnant Women

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 31, 2026 to Jan 31, 2028
    • Study completion date: Jun 30, 2026 to Jun 30, 2028
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Primary completion date: Jan 31, 2024 to Jan 31, 2026
    • Study completion date: Jul 31, 2024 to Jun 30, 2026
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2023 to Mar 1, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized clinical trial is to assess sulfasalazine as a potential treatment to prevent recurrent preterm birth. The main questions it aims to answer are: * Does sulfasalazine down regulate corticotropin releasing hormone (CRH) levels in pregnant persons with a prior history of preterm birth? * Does sulfasalazine reduce the incidence of recurrent preterm birth in pregnant persons given drug vs. controls? Consenting participants will be randomized to receive sulfasalazine or to a control group and will undergo serial blood draws to assess plasma CRH levels.
Trial Details
NCT Number NCT05703425
Lead Sponsor Rutgers, The State University of New Jersey
Conditions
(from sponsor)		 Preterm Birth
Related terms Premature Birth
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov