The Effect of Sulfasalazine on CRH Levels in Pregnant Women

• Status: Not yet recruiting
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Sulfasalazine

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.