NCT05703425 The Effect of Sulfasalazine on CRH Levels in Pregnant Women
| NCT ID | NCT05703425 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2023-03-01 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Emily Rosenfeld, DO
PRINCIPAL INVESTIGATOR
Rutgers Robert Wood Johnson Medical School
Frequently Asked Questions
Who can join the NCT05703425 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05703425 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05703425 currently recruiting?
Yes, NCT05703425 is actively recruiting participants. Contact the research team at vm310@rwjms.rutgers.edu for enrollment information.
Where is the NCT05703425 trial being conducted?
This trial is being conducted at New Brunswick, United States.
Who is sponsoring the NCT05703425 clinical trial?
NCT05703425 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Emily Rosenfeld, DO at Rutgers Robert Wood Johnson Medical School. The trial plans to enroll 50 participants.