RECRUITING

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05703425

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \> 18 years of age
  2. * Singleton pregnancy
  3. * Participants with a history of prior preterm birth in a previous pregnancy
  4. * Participants must be between 12 and 22 weeks gestation.
  5. * Participants must have their pregnancy dates confirmed by ultrasound.
  1. * Participants \< 18 years old
  2. * Participants with a cervical length \< 25 mm
  3. * Participants with a multiple gestation
  4. * Cerclage
  5. * Progesterone administration
  6. * Unwilling or unable to swallow the study agent capsule or consume an inert ingredient in the study agent capsule
  7. * Acute liver disease or known liver abnormalities
  8. * Other significant chronic medical or psychiatric illness that, in the investigator's opinion, would prevent participation in the study
  9. * Known hypersensitivity to sulfasalazine
  10. * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  11. * History of severe asthma
  12. * Digoxin use
  13. * Porphyria
  14. * Intestinal obstruction
  15. * Urinary tract obstruction
  16. * Hepatic dysfunction
  17. * Renal dysfunction
  18. * Blood dyscrasia such as agranulocytosis, aplastic anemia.

Contacts and Locations

Study Contact

Shama Khan, MS
CONTACT
732-407-6421
khansp@rwjms.rutgers.edu
Todd Rosen, MD
CONTACT
732-491-5787
rosentj@rwjms.rutgers.edu

Principal Investigator

Todd Rosen, MD
PRINCIPAL_INVESTIGATOR
Rutgers Robert Wood Johnson Medical School

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • preterm birth
  • sulfasalazine
  • corticotropin releasing hormone
  • randomized controlled trial

Additional Relevant MeSH Terms

  • Preterm Birth