Recruiting
Phase 2

Sulfasalazine

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05703425

Conditions

Preterm Birth

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sulfasalazine

Study Details

Brief summary:

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.

Conditions

Preterm Birth

Study ID

NCT05703425

Start date

Mar 1, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Sulfasalazine

Sulfasalazine will be administered between 24 and 36 weeks of pregnancy

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Vanessa Martinez, MPH

2017379179vm310@rwjms.rutgers.edu

Emily Rosenfeld, DO

7324024960er720@rwjms.rutgers.edu

Locations

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Jessica Fields, MD

732-235-6632jf993@rwjms.rutgers.edu

Shama Khan, MS

732-235-6632khansp@rwjms.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • preterm birth
  • sulfasalazine
  • corticotropin releasing hormone
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-07-09.