NCT05703425 · Rutgers, The State University of New Jersey
The Effect of Sulfasalazine on CRH Levels in Pregnant Women
What this study is about
The goal of this randomly assigned clinical trial is to assess sulfasalazine as a potential treatment to prevent recurrent preterm birth.
View original scientific description
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.
Interventions
DRUG
Sulfasalazine
Sulfasalazine will be administered between 24 and 36 weeks of pregnancy
Primary outcome measures
Serum CRH levels
Time frame: between 28 and 36 weeks of pregnancy
CRH will be assessed at 28, 32, and 36 weeks gestation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Intestinal obstruction
- Urinary tract obstruction
- Hepatic dysfunction
- Renal dysfunction
- Blood dyscrasia such as agranulocytosis, aplastic anemia.
Where
- New Brunswick, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations