Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05703425

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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