The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Recruiting now · Phase 2

Conditions studied: Preterm Birth

In brief

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 facts

Study ID

NCT05703425

Run by

Rutgers, The State University of New Jersey

People needed

50

Starts

2023-03-01

Expected to finish

2028-06-30

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• > 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.

You may not qualify if…

• 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.

Where it is running

• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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