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Treating preterm preeclampsia with sulfasalazine: An early phase clinical trial

Pharmacokinetics of sulfasalazine for the treatment of preterm preeclampsia: An early phase clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000226303
Enrollment
2
Registered
2017-02-13
Start date
2018-01-31
Completion date
Unknown
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Preeclampsia is a common, serious complication of pregnancy and leading cause of maternal, fetal and neonatal death and disability. Currently there is no medical treatment and the only way to stop disease progression is to deliver the pregnancy. At early gestations this inflicts the serious risks of prematurity on the newborn whilst the mother is exposed to the risk of disease progression during the delivery process. A treatment that stabilises the disease to allow the safe prolongation of pregnancy would be a major advance. Excitingly we have discovered that a medication safe in pregnancy, sulfasalazine, can reverse key features of preeclampsia disease pathophysiology in laboratory studies using primary human pregnancy tissues. Firstly we showed that sulfasalazine reduces the placental secretion of antiangiogenic factors sFlt-1 and soluble endoglin that cause preeclampsia. Secondly we demonstrated sulfasalazine reduced features of vascular dysfunction specific to preeclampsia. Given these promising findings and that sulfasalazine is safe in pregnancy (category B) we hope to progress this concept and translate these findings from the laboratory to the clinic with a proof of concept early phase clinical trial. We propose to recruit 20 women with preterm preeclampsia (30+0 weeks to 36+0 weeks gestation) at The Mercy Hospital for Women and treat them with 2-3 grams of sulfasalazine per day. We will assess the pharmacokinetics of sulfasalazine in women with preeclampsia and monitor key clinical and biochemical features of the disease. If successful, at the completion of this study, we will have evidence to progress the study of sulfasalazine as a treatment for preeclampsia to randomized clinical trial. It may form the basis for a medical treatment for preeclampsia and reduce the devastating burden of this common obstetric disease.

Interventions

3 grams of sulfasalazine will be administered orally daily to participants until they require delivery. Patients will be admitted and adherence monitored using the in patient drug chart.

Sponsors

Mercy Hospital for Women
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

The diagnosis of preeclampsia will be made using the Society of Obstetric Medicine Australia and New Zealand guidelines. Eligible women will be 18 years or older with singleton, non-anomalous pregnancies between 30+0 and 36+0 weeks gestation.

Exclusion criteria

We will exclude women with multiple pregnancy, known fetal malformation, contraindication to sulfasalazine treatment, women already taking sulfasalazine and women with an immunodeficiency disorder.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026