The Effect of Sulfasalazine on CRH Levels in Pregnant Women

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.

Conditions

Preterm Birth

Study Overview

Study Details

Study overview

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.

The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Condition
Preterm Birth
Intervention / Treatment

-

Contacts and Locations

New Brunswick

Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Rutgers, The State University of New Jersey,

Todd Rosen, MD, PRINCIPAL_INVESTIGATOR, Rutgers Robert Wood Johnson Medical School

Study Record Dates

2026-06-30