Actively Recruiting
The Effect of Sulfasalazine on CRH Levels in Pregnant Women
Led by Rutgers, The State University of New Jersey · Updated on 2025-09-22
50
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Sulfasalazine on CRH Levels in Pregnant Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Singleton pregnancy
- History of prior preterm birth in a previous pregnancy
- Between 12 and 22 weeks gestation
- Pregnancy dates confirmed by ultrasound
You will not qualify if you...
- Under 18 years old
- Cervical length less than 25 mm
- Multiple gestation
- Cerclage placement
- Progesterone administration
- Unable or unwilling to swallow study capsule or consume inert ingredients
- Acute liver disease or known liver abnormalities
- Significant chronic medical or psychiatric illness preventing study participation
- 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 disorders such as agranulocytosis or aplastic anemia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
V
Vanessa Martinez, MPH
CONTACT
E
Emily Rosenfeld, DO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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