The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial
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.
Description
This is a study to assess the potential for sulfasalazine to prevent recurrent preterm birth. The investigators' main objective is to assess the effects of sulfasalazine on the maternal serum biomarker CRH, which is associated with preterm birth. The will be a pilot randomized controlled trial of pregnant multiparous patients who have had a prior preterm delivery. Pregnant women with a prior preterm birth are at high risk (about 20-30%) of having a recurrent preterm birth. The goal of the study will be to evaluate the effect of sulfasalazine on the maternal serum biomarker CRH at 28, 32, and…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
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 l…
Interventions
- DrugSulfasalazine
Sulfasalazine will be administered between 24 and 36 weeks of pregnancy
Location
- Rutgers Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey