The Effect of Sulfasalazine on CRH Levels in Pregnant Women

NCT05703425 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro2021001951
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Serum CRH levels

  CRH will be assessed at 28, 32, and 36 weeks gestation

  between 28 and 36 weeks of pregnancy

Secondary Outcomes (5)

• Spontaneous preterm birth < 37 weeks gestation

  up to 37 weeks of pregnancy

• Spontaneous preterm birth < 34 weeks gestation

  up to 34 weeks of pregnancy

• Medically indicated preterm birth < 37 weeks gestation

  up to 37 weeks of pregnancy

• Digital cervical exam at 36 weeks gestational age

  between 35 weeks and 36 weeks 6 days of pregnancy

• Composite neonatal morbidity

  From birth of the neonate until 28 days of life

Study Arms (2)

Sulfasalazine

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Pregnant persons will receive standard care in pregnancy.

Interventions

Sulfasalazine DRUG

Sulfasalazine will be administered between 24 and 36 weeks of pregnancy

Sulfasalazine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Publications (6)

• McLean M, Bisits A, Davies J, Woods R, Lowry P, Smith R. A placental clock controlling the length of human pregnancy. Nat Med. 1995 May;1(5):460-3. doi: 10.1038/nm0595-460.

  PMID: 7585095 BACKGROUND

• Wang B, Parobchak N, Rosen T. RelB/NF-kappaB2 regulates corticotropin-releasing hormone in the human placenta. Mol Endocrinol. 2012 Aug;26(8):1356-69. doi: 10.1210/me.2012-1035. Epub 2012 Jun 25.

  PMID: 22734038 BACKGROUND

• Wang B, Parobchak N, Martin A, Rosen M, Yu LJ, Nguyen M, Gololobova K, Rosen T. Screening a small molecule library to identify inhibitors of NF-kappaB inducing kinase and pro-labor genes in human placenta. Sci Rep. 2018 Jan 26;8(1):1657. doi: 10.1038/s41598-018-20147-0.

  PMID: 29374256 BACKGROUND

• Norgard B, Fonager K, Pedersen L, Jacobsen BA, Sorensen HT. Birth outcome in women exposed to 5-aminosalicylic acid during pregnancy: a Danish cohort study. Gut. 2003 Feb;52(2):243-7. doi: 10.1136/gut.52.2.243.

  PMID: 12524407 BACKGROUND

• Mogadam M, Dobbins WO 3rd, Korelitz BI, Ahmed SW. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology. 1981 Jan;80(1):72-6.

  PMID: 6108894 BACKGROUND

• Hensleigh PA, Kauffman RE. Maternal absorption and placental transfer of sulfasalazine. Am J Obstet Gynecol. 1977 Feb 15;127(4):443-4. doi: 10.1016/0002-9378(77)90510-5. No abstract available.

  PMID: 13655 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Sulfasalazine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Emily Rosenfeld, DO

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Martinez, MPH

CONTACT

2017379179; vm310@rwjms.rutgers.edu

Emily Rosenfeld, DO

CONTACT

7324024960; er720@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RBHS Instructor, Divisions of Maternal-Fetal Medicine, and Epidemiology and Biostatistics

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 30, 2023
• Study Start: March 1, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available on publication and remain available for two years.
• Access Criteria: The principal investigator will individually assess all requests for data.

Locations

US (1)