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Anti-inflammatory

Sulfasalazine for Preventing Premature Birth

Phase 2

Recruiting

Led By Todd Rosen, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 35 weeks and 36 weeks 6 days of pregnancy

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if sulfasalazine can prevent preterm birth in pregnant people with a history of preterm birth by reducing CRH levels. Participants will be randomly assigned to get the drug or a control group.

Who is the study for?

This trial is for pregnant women over 18, between 12-22 weeks gestation, with a history of preterm birth and a confirmed singleton pregnancy. It's not for those under 18 or with certain medical conditions like severe asthma, liver/renal dysfunction, blood disorders, G6PD deficiency, or allergies to sulfasalazine.

What is being tested?

The study tests if sulfasalazine can lower CRH levels in pregnant women who've had early births before and if it can prevent another premature birth. Participants will be randomly assigned to either receive the drug or be in a control group.

What are the potential side effects?

Sulfasalazine may cause side effects such as digestive issues (nausea, vomiting), headaches, potential allergic reactions for those sensitive to the medication, and changes in blood counts which could lead to anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 35 weeks and 36 weeks 6 days of pregnancy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 35 weeks and 36 weeks 6 days of pregnancy

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 35 weeks and 36 weeks 6 days of pregnancy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serum CRH levels

Secondary study objectives

Composite neonatal morbidity

Digital cervical exam at 36 weeks gestational age

Medically indicated preterm birth < 37 weeks gestation

+2 more

Side effects data

From 2015 Phase 4 trial • 400 Patients • NCT01172639

33%

Upper respiratory tract infection

26%

Abdominal pain

23%

Nausea

19%

Gastroenteritis

16%

Hairloss

14%

Liver function disturbance

12%

Tendinopathy

12%

Arthralgia

Eczema

Vertigo

Hypertension

Increased transpiration

Arthrosis

Back pain

Agitation

Tooth extraction

Paresthesia

Pruritus

Sjogren's disease

Venous insufficiency

Palpitations

Anaemia

Influenza infection

Fatigue

Muscle cramps

Headache

Bronchitis

General malaise

Arthritis

Flushes

Endometrioid adenocarcinoma

Pyrosis

Intervertebral disc disorder

Rotator cuff lesion

Bladder infection

Eye infection

Insomnia

Diarrhoea

Angina

Kidney cancer malignant

Pneumonia

Cough

Genital infection

100%

80%

60%

40%

20%

Study treatment Arm

CoBRA Slim Low Risk Group

Tight Step Up Low Risk Group

CoBRA Classic High Risk Group

CoBRA Slim High Risk Group

CoBRA Avant-garde High Risk Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SulfasalazineExperimental Treatment1 Intervention

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.

Group II: Standard CareActive Control1 Intervention

Pregnant persons will receive standard care in pregnancy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulfasalazine

2016

Completed Phase 4

~1860

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