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New treatment option for Preterm Birth
Official title The Effect of Sulfasalazine on CRH Levels in Pregnant Women
ClinicalTrials.gov ID: NCT05703425
What this study is testing
What is Sulfasalazine?
Sulfasalazine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for preterm birth.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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
See the full 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.