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Sulfasalazine for Preventing Recurrent Preterm Birth

This study is looking at whether a medication called sulfasalazine can help prevent preterm birth (delivery before 37 weeks of pregnancy) in women who have had a preterm birth before. Researchers want to see if sulfasalazine can lower levels of a hormone called corticotropin releasing hormone (CRH) in your blood, which is linked to preterm birth. You might be able to join if you are over 18, pregnant with one baby, have had a preterm birth in the past, and are between 12 and 22 weeks pregnant. Success for this study would mean that sulfasalazine lowers CRH levels and reduces the chance of another preterm birth. The current status of this study is unclear.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to receive sulfasalazine or be in a control group. The study plans to enroll 50 pregnant women.
What's involved
Participants will receive sulfasalazine between 24 and 36 weeks of pregnancy. You will also have blood draws to check CRH levels at 28, 32, and 36 weeks of pregnancy.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for this study measures CRH levels between 28 and 36 weeks of pregnancy. The study also assesses delivery outcomes and neonatal outcomes, but specific follow-up duration is not detailed.

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NCT05703425

The Effect of Sulfasalazine on CRH Levels in Pregnant Women

Recruiting
PHASE2Ages 18+InterventionalTreatment
Rutgers, The State University of New Jersey
~50 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Sulfasalazine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serum CRH levels
Measured over between 28 and 36 weeks of pregnancy

Conditions

Preterm Birth

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Preterm Birth

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Emily Rosenfeld, DO · PRINCIPAL_INVESTIGATOR · Rutgers Robert Wood Johnson Medical School

Who to contact

Vanessa Martinez, MPH
[email protected]
2017379179
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\> 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

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.

What this trial measures

  • Serum CRH levelsbetween 28 and 36 weeks of pregnancy

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