A Phase 2 interventional study of Sulfasalazine in Preterm Birth, sponsored by Rutgers, The State University of New Jersey. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
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:
Consenting participants will be randomized to receive sulfasalazine or to a control group and will undergo serial blood draws to assess plasma CRH levels.
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 36 weeks gestation after randomization of patients to the study drug.
Secondary objectives include evaluating the effect of sulfasalazine on the outcome of delivery less than 37 weeks gestation in this group of high risk pregnant women. Additional composite neonatal outcomes will be assessed.
The proposed study has the potential to identify a novel, low-cost, orally available treatment for preterm delivery based on in vitro evidence and epidemiologic studies suggesting that sulfasalazine may be an effective intervention to prevent preterm birth. If the hypothesis put forth by the investigators is confirmed, sulfasalazine would be an attractive therapeutic intervention that could be implemented for the prevention of preterm birth in both developed and developing nations.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 50 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pregnant persons will receive sulfasalazine daily with 500 mg/daily and increasing by 500 mg/day every week until they reach a therapeutic dose of 1,000 mg twice daily. Drug will be started at 24 weeks estimated gestational age and ended at 36 weeks or earlier if preterm birth occurs.
Drug: Sulfasalazine
Pregnant persons will receive standard care in pregnancy.
Sulfasalazine will be administered between 24 and 36 weeks of pregnancy
Serum CRH levels
CRH will be assessed at 28, 32, and 36 weeks gestation
Time frame: between 28 and 36 weeks of pregnancy
Spontaneous preterm birth < 37 weeks gestation
Preterm births prior to 37 weeks secondary to preterm labor (PTL) or premature Preterm births secondary to preterm labor or preterm rupture of the membranes (PPROM)
Time frame: up to 37 weeks of pregnancy
Spontaneous preterm birth < 34 weeks gestation
Preterm births prior to 34 weeks secondary to PTL or PPROM
Time frame: up to 34 weeks of pregnancy
Medically indicated preterm birth < 37 weeks gestation
Preterm births due to maternal or fetal disease not related to PTL or PPROM
Time frame: up to 37 weeks of pregnancy
Digital cervical exam at 36 weeks gestational age
Digital cervical exam at 36 weeks gestational age
Time frame: between 35 weeks and 36 weeks 6 days of pregnancy
Composite neonatal morbidity
Composite outcome including but not limited to Apgar neonatal death, respiratory distress, necrotizing enterocolitis, and bronchopulmonary dysplasia.
Time frame: From birth of the neonate until 28 days of life
Plan to share: Yes — Deidentified data will be provided to those inquire to the corresponding author of the manuscript if published. If no manuscript is published, inquiries can be directed to the principal investigator of the study.
Supporting information: Study protocol, Sap, Icf, Csr
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Rutgers, The State University of New Jersey