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RecruitingAccepts healthy volunteersPhase 2

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Rutgers, The State University of New Jersey · NCT05703425

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
50
US sites recruiting
1
Study start
March 1, 2023
Record last updated
July 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Sulfasalazine

Conditions: Preterm Birth

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • > 18 years of age
  • Singleton pregnancy
  • Participants with a history of prior preterm birth in a previous pregnancy
  • Participants must be between 12 and 22 weeks gestation.
  • Participants must have their pregnancy dates confirmed by ultrasound.

Exclusion Criteria

  • Participants \< 18 years old
  • Participants with a cervical length \< 25 mm
  • Participants with a multiple gestation
  • Cerclage
  • Progesterone administration
  • Unwilling or unable to swallow the study agent capsule or consume an inert ingredient in the study agent capsule
  • Acute liver disease or known liver abnormalities
  • Other significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study
  • Known hypersensitivity to sulfasalazine
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • History of severe asthma
  • Digoxin use
  • Porphyria
  • Intestinal obstruction
  • Urinary tract obstruction
  • Hepatic dysfunction
  • Renal dysfunction
  • Blood dyscrasia such as agranulocytosis, aplastic anemia.

Recruiting US locations

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, NJ 08901

    Site contact: Jessica Fields, MD · 732-235-6632 · jf993@rwjms.rutgers.edu

Study contacts (from the official record)

  • Vanessa Martinez, MPH · 2017379179 · vm310@rwjms.rutgers.edu
  • Emily Rosenfeld, DO · 7324024960 · er720@rwjms.rutgers.edu
All pregnancy studies in New Jersey →
The Effect of Sulfasalazine on CRH Levels in Pregnant Women (NCT05703425) | Bored Studies