Health TrialsbyHealthPanel

Aspirin for Postpartum Patients With Preeclampsia

ConditionPreeclampsia Postpartum
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorialCare Health System

About this trial

The purpose of this research study is to evaluate the effect of low-dose aspirin on recovery from severe preeclampsia (a high blood pressure disorder of pregnancy) among women who have given birth. We hypothesize that taking aspirin for the first week after giving birth will enhance recovery from preeclampsia by decreasing the levels of a protein called soluble fms-like tyrosine kinase (sFlt-1), which is thought to be a main contributor to the development of preeclampsia, and speeding up return to a normal blood pressure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preeclampsia with severe features diagnosed during delivery admission, as defined by ACOG criteria.

Pre- and postnatal care provided by the Long Beach Memorial Ob/Gyn resident or Maternal-Fetal Medicine clinic.

Disqualifiers

Patient age <18 years old

Non-English or Non-Spanish speaking

Chronic hypertension diagnosed before 20 weeks' gestation

Known allergy, prior adverse reaction, or any medical condition in which aspirin is contraindicated (nasal polyps, gastric or duodenal ulcers, history of gastrointestinal bleeding, severe hepatic dysfunction)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin 81Mg Ec Tab

    Drug

    Aspirin 81 mg 1 tablet by mouth. Participants randomized to receive aspirin in addition to standard blood pressure management will receive the study medication nightly at 20:00, with first dose initiated within 24 hours of delivery.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Standard blood pressure control plus aspirin 81 mgExperimental treatment 1 intervention
Group B: Standard blood pressure controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reduction in sFlt-1

This outcome will determine the absolute change in sFlt-1, an anti-angiogenic protein implicated in the pathophysiology of preeclampsia.

Time frame
1 week postpartum

Secondary outcomes

1

Normotension (ACOG)

This outcome will measure the proportion of patients who achieve a blood pressure of \<140/90, as defined by ACOG, without any further elevated values.

Time frame
1 week postpartum
2

Normotension (JNC)

This outcome will measure the proportion of patients who achieve a blood pressure of \<130/80, as defined by JNC, without any further elevated values.

Time frame
1 week postpartum
3

Time to normotension

This outcome will assess the length of time in days to normotension after randomization. Normotension will be defined by both ACOG and JNC criteria.

Time frame
6 weeks postpartum
4

Anti-hypertensive therapy

This outcome will assess if additional or increased doses of anti-hypertensive therapies are needed following randomization.

Time frame
6 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MemorialCare Health System

Lead sponsor

University of California, Irvine

Collaborator

Source ClinicalTrials.gov
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