The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05703425
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sulfasalazine — DRUG
    Sulfasalazine will be administered between 24 and 36 weeks of pregnancy

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Sep 2025
Primary completion
Jan 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Sulfasalazine
    Pregnant persons will receive sulfasalazine daily with 500 mg/daily and increasing by 500 mg/day every week until they reach a therapeutic dose of 1,000 mg twice daily. Drug will be started at 24 weeks estimated gestational age and ended at 36 weeks or earlier if preterm birth occurs.
  • No Intervention: Standard Care
    Pregnant persons will receive standard care in pregnancy.

Primary Outcome Measure

Serum CRH levels [ Time Frame: between 28 and 36 weeks of pregnancy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901
Jessica Fields, MD
[email protected]
732-235-6632
Shama Khan, MS
[email protected]
732-235-6632

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By research site
Rutgers Robert Wood Johnson Medical School· New Brunswick, NJ

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