RecruitingPhase 2NCT05703425

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial

Sponsor

Rutgers, The State University of New Jersey

Enrollment

50 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Preterm Birth

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

> 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 Criteria18

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.