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NCT05703425
The Effect of Sulfasalazine on CRH Levels in Pregnant Women
Conditions: Preterm Birth
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 50
Sponsor: Rutgers, The State University of New Jersey
Location: Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey
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 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.
Source: ClinicalTrials.gov (NCT05703425). StuddyBuddy aggregates publicly available trial information.