AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorOhio State University
About this trial
The objective is to conduct a double-blinded randomized controlled trial of atorvastatin vs. placebo among postpartum individuals with hypertensive disorders of pregnancy, to improve cardiovascular risk score postpartum. For this, 76 individuals with hypertensive disorders of pregnancy (HDP) will be randomized to atorvastatin 10mg or placebo, which will be started in the postpartum period after cessation of breast feeding and continued for 3 months.
Eligibility criteria
Qualifiers
Postpartum
≥ 20 years old with the ability to give informed consent
Diagnosis of gestational hypertension, preeclampsia prior to delivery admission, or diagnosed with preeclampsia during delivery admission, as determined by clinical team using the American College of Obstetricians and Gynecologists (ACOG) criteria.
English speaking
Disqualifiers
Individuals who were prescribed an 3-hydroxy-3 methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitor prior to or during pregnancy,
Known familial hypercholesterolemia or pre-existing hyperlipidemia, specifically Low-density Lipoprotein (LDL) >190 prior to pregnancy or diagnosis of hyperlipidemia with prescription of HMG-CoA reductase inhibitor prior to delivery,
Plan to breastfeed for >= 6 months,
Plan for pregnancy conception in the next 6 months,
Trial design
Treatments tested in this trial
- Atorvastatin 10 mg
- Placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov