Using sulfasalazine to lower hormone levels and prevent preterm birth in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial aims to evaluate the effectiveness of sulfasalazine in preventing recurrent preterm birth among pregnant women with a history of preterm delivery. Participants will be randomly assigned to receive either sulfasalazine or a control treatment, with blood samples taken to measure levels of corticotropin releasing hormone (CRH) at various stages of pregnancy. The study will assess both the impact of sulfasalazine on CRH levels and its potential to reduce the incidence of preterm birth. The findings could lead to a low-cost treatment option for preventing preterm births in high-risk populations.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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.

Where it's running

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

Study contacts

• Principal investigator: Emily Rosenfeld, DO — Rutgers Robert Wood Johnson Medical School
• Study coordinator: Vanessa Martinez, MPH
• Email: vm310@rwjms.rutgers.edu
• Phone: 2017379179

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting Adverse Pregnancy Outcomes in Uganda through Partnerships and Innovation

  This study tests whether everyday health data, ultrasound, and blood samples from first-time pregnant women in Uganda can help predict problems like preeclampsia, fetal growth restriction, and preterm birth.

  Recruiting at 2 sites Makerere University · Kampala and 1 other locations · NCT07844876

• Cervical stiffness test to help predict preterm birth in at-risk pregnant women

  A simple cervical stiffness test using the Pregnolia device is being studied to see if it can better identify women with threatened preterm labor who are likely to give birth soon.

  Recruiting Pregnolia AG · Prague · NCT07840235

• Prenatal education to reduce environmental exposures during pregnancy

  Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.

  Recruiting at 2 sites The University of Texas Medical Branch, Galveston · Galveston, Texas and 1 other locations · NCT07758114

• How doctors and nurses decide about bed rest in pregnancy

  This study tests a plan to stop routinely restricting activity or bed rest during pregnancy to see if providers accept it, find it appropriate, and change how often they recommend it for women at risk of preterm birth.

  Recruiting at 2 sites University of Pennsylvania · Philadelphia, Pennsylvania and 1 other locations · NCT07698483

• How cervical ultrasound settings affect AI prediction of preterm birth

  This study tests whether an AI model for predicting preterm birth performs differently when cervical ultrasound images are taken with different imaging settings.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07598097

• Routine STI screening during pregnancy to improve birth outcomes

  This study tests whether adding screening and treatment for chlamydia and gonorrhoea to standard antenatal care can reduce preterm birth and other problems for pregnant women in Botswana.

  Recruiting University of California, San Diego · Gaborone · NCT07458802

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.