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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
Who can join
Ages 18 and older · Women · Healthy volunteers welcome
Full 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.
About the study
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.
What is being tested
- Sulfasalazine (drug)
Sponsor: Rutgers, The State University of New Jersey · Participants: 50 · Started: Mar 1, 2023
Contact the study team
- Vanessa Martinez, MPH · Phone: 2017379179
- Emily Rosenfeld, DO · Phone: 7324024960
Official record on ClinicalTrials.gov — NCT05703425
Locations in the U.S.
| New Jersey | Rutgers Robert Wood Johnson Medical School, New Brunswick |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.