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The Effect of Sulfasalazine on CRH Levels in Pregnant Women

RecruitingPhase 2Ages 18 Years - anyFemaleRutgers, The State University of New Jersey
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Sulfasalazine
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Where

1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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