Using sulfasalazine to lower hormone levels and prevent preterm birth in pregnant women
The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial
PHASE2 · Rutgers, The State University of New Jersey · NCT05703425
This study is testing if the medication sulfasalazine can help pregnant women who have had preterm births by lowering certain hormone levels and preventing them from having another preterm birth.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT05703425 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of sulfasalazine in preventing recurrent preterm birth among pregnant women with a history of preterm delivery. Participants will be randomly assigned to receive either sulfasalazine or a control treatment, with blood samples taken to measure levels of corticotropin releasing hormone (CRH) at various stages of pregnancy. The study will assess both the impact of sulfasalazine on CRH levels and its potential to reduce the incidence of preterm birth. The findings could lead to a low-cost treatment option for preventing preterm births in high-risk populations.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 years old with a singleton pregnancy and a history of prior preterm birth, between 12 and 22 weeks gestation.
Not a fit: Patients with multiple gestations, significant medical conditions, or contraindications to sulfasalazine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the rates of recurrent preterm birth in at-risk pregnant women.
How similar studies have performed: While sulfasalazine has shown promise in preliminary studies, this specific application for preventing preterm birth is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Brunswick, New Jersey
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Emily Rosenfeld, DO — Rutgers Robert Wood Johnson Medical School
- Study coordinator: Vanessa Martinez, MPH
- Email: vm310@rwjms.rutgers.edu
- Phone: 2017379179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Birth, preterm birth, sulfasalazine, corticotropin releasing hormone, randomized controlled trial