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Not Yet Recruiting NCT05703425

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Conditions: Preterm Birth

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 50
Sponsor: Rutgers, The State University of 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 ageSingleton pregnancyParticipants with a history of prior preterm birth in a previous pregnancyParticipants must be between 12 and 22 weeks gestation.Participants must have their pregnancy dates confirmed by ultrasound.Exclusion Criteria:Participants < 18 years oldParticipants with a cervical length < 25 mmParticipants with a multiple gestationCerclageProgesterone administrationUnwilling or unable to swallow the study agent capsule or consume an inert ingredient in the study agent capsuleAcute liver disease or known liver abnormalitiesOther significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the studyKnown hypersensitivity to sulfasalazineKnown glucose-6-phosphate dehydrogenase (G6PD) deficiencyHistory of severe asthmaDigoxin usePorphyriaIntestinal obstructionUrinary tract obstructionHepatic dysfunctionRenal dysfunctionBlood dyscrasia such as agranulocytosis, aplastic anemia.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05703425). StuddyBuddy aggregates publicly available trial information.