Using ravulizumab to treat severe preeclampsia in pregnant women
Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
This study is testing if the medication ravulizumab can help pregnant women with severe preeclampsia and HELLP syndrome feel better and stay safe.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | Ravulizumab |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06333652 on ClinicalTrials.gov |
What this trial studies
This clinical trial is investigating the efficacy of ravulizumab, a medication, in treating severe preeclampsia and HELLP syndrome in pregnant women who are less than 34 weeks gestation. The study aims to assess the safety and effectiveness of this intervention in managing these serious pregnancy complications. Participants will be closely monitored for improvements in their condition and any potential side effects from the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women under 34 weeks of gestation diagnosed with severe preeclampsia or HELLP features.
Not a fit: Patients with conditions such as disseminated intravascular coagulopathy, non-viable fetuses, or those requiring immediate delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for pregnant women suffering from severe preeclampsia and HELLP syndrome.
How similar studies have performed: While this approach is novel in the context of severe preeclampsia, similar studies using targeted therapies for pregnancy-related complications have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with \< 34 0/7 weeks of gestation. * Individuals with severe preeclampsia or HELLP features. Exclusion Criteria: * Pregnant female patients presenting with disseminated intravascular coagulopathy (DIC). * Individuals with non-reassuring fetal status requiring delivery, non-viable fetuses, previable pregnancy (\<23 0/7 weeks gestation), stroke, in utero fetal demise, known atypical hemolytic uremic syndrome, familial or acquired thrombocytopenia purpura, paroxysmal nocturnal hemoglobinuria, allergy to Ravulizumab, inability or unwillingness to sign informed consent.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Maria Lourdes Gonzalez Suarez, MD, PhD — Mayo Clinic
- Study coordinator: Gonzalez Suarez
- Phone: 507-284-2511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.