Recruiting

Aspirin

Sponsor:

Malamo Countouris

Code:

NCT06281665

Conditions

Hypertensive Disorder of Pregnancy

Pre-Eclampsia

Hypertension

Eclampsia

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Low-dose aspirin

Placebo

Study Details

Brief summary:

The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

Conditions

Hypertensive Disorder of Pregnancy

Pre-Eclampsia

Hypertension

Eclampsia

Gestational Hypertension

Study ID

NCT06281665

Start date

May 29, 2024

Status verified date

Jun, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Postpartum individuals ≥18 years old
  • Preeclampsia diagnosis

Exclusion Criteria:

  • Fetal anomaly
  • Multiple gestation
  • Pre-pregnancy hypertension
  • Allergy or contraindication to low-dose aspirin
  • Pre-pregnancy diabetes

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Group

Similar appearing placebo pill daily for 6 months will be given to subjects.

experimental: Intervention Group

Low-dose \[81 mg\] aspirin pill daily for 6 months will be given to subjects

Interventions

Low-dose aspirin

The intervention group will receive low-dose \[81 mg\] aspirin pill daily for 6 months.

Placebo

The control group will receive similar appearing placebo daily for 6 months.

Primary outcome measure

  • Percent of participants eligible, enrolled and retained (feasibility) [ Time Frame: Baseline to approximately 6 months postpartum ]

Central Contacts and Locations

Central contacts

Locations

University of Pittsburgh Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Principal Investigator:

Alisse K Hauspurg, MD

More Information

Sponsor

Malamo Countouris

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Malamo Countouris on 2026-06-04.