Preterm BirthPhase 2NCT05703425
The Effect of Sulfasalazine on CRH Levels in Pregnant Women
A Phase 2 study testing Sulfasalazine in people with Preterm Birth, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Sulfasalazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 30 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Jessica Fields, MD, 732-235-6632, jf993@rwjms.rutgers.edu
Shama Khan, MS, 732-235-6632, khansp@rwjms.rutgers.edu
About this study
Official title: The Effect of Sulfasalazine on CRH Levels in Pregnant Women With a History of Pre-Term Birth: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Preterm Birth
- Being tested
- Sulfasalazine
- Keywords
- preterm birth, sulfasalazine, corticotropin releasing hormone, randomized controlled trial
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
Sulfasalazine will be administered between 24 and 36 weeks of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sulfasalazine |
| Standard Care | No intervention | Pregnant persons will receive standard care in pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CRH levels
CRH will be assessed at 28, 32, and 36 weeks gestation
Measured: between 28 and 36 weeks of pregnancy
Secondary outcomes (5)
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)
Measured: up to 37 weeks of pregnancy
Spontaneous preterm birth < 34 weeks gestation
Preterm births prior to 34 weeks secondary to PTL or PPROM
Measured: 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
Measured: up to 37 weeks of pregnancy
Digital cervical exam at 36 weeks gestational age
Digital cervical exam at 36 weeks gestational age
Measured: 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.
Measured: From birth of the neonate until 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily B. Rosenfeld, DO, Rutgers, The State University of New Jersey
- Investigators
- Emily Rosenfeld, DO, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703425
- Sponsor's protocol ID
- Pro2021001951
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 7585095Wang 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.
PubMed 22734038Wang 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.
PubMed 29374256Norgard 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.
PubMed 12524407Mogadam 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.
PubMed 6108894Hensleigh 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.
PubMed 13655