Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida

The University of Texas Health Science Center, Houston220 enrolled

Overview

To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Pre-Eclampsia Hypertension in Pregnancy Obesity

Interventions

Aspirin 81 mgDRUG

Low dose aspirin was initially reported as having a beneficial effect at preeclampsia

Aspirin 162 mgDRUG

Low dose aspirin was initially reported as having a beneficial effect at preeclampsia

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria * A singleton gestation at less than 20 weeks at time of enrollment, with a BMI greater than or equal to 30 and one of the following: 1\. History of preeclampsia in a prior pregnancy * Diagnosis will be obtained by review of records, and if unavailable then patient history. Preeclampsia diagnosis may be made in antepartum or postpartum period. OR 2. At least stage I hypertension during pregnancy * Stage I hypertension is defined as a systolic blood pressure between 130- 139 mm Hg or diastolic blood pressure between 80-89 mm Hg21 * This blood pressure criteria is met regardless of medication usage * The patient must have a blood pressure reading ≥ 130-139/80-89 mm Hg at least during 1 clinic visit during the current pregnancy; before or at time of enrollment OR 3\. Pre-gestational diabetes * Type 1 and Type 2 diabetics are included * Gestational diabetes mellitus diagnosed prior to 20 weeks gestational age will also be included Exclusion Criteria * Known allergy/prior adverse reaction/any medical condition where aspirin is contraindicated * Already on aspirin prior to pregnancy * Baseline renal Disease * Baseline proteinuria identified at time of enrollment, defined as urine analysis with 3+ protein, or urine protein to creatinine ratio ≥ 0.3 * Systemic Lupus Erythematosus * Seizure disorder on medications * HIV positive status * Known major fetal anomalies * Multifetal gestation

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis

based on American College Obstetrics and Gynecology (ACOG) guidelines

Time frame: 3-7 months

Secondary Outcomes

Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features

Time frame: less than 37 weeks gestational age (GA)

Maternal Outcomes-Number of Participants With Gestational Hypertension

development of hypertension anytime during pregnancy based on ACOG guidelines

Time frame: 3-7 months

Maternal Outcomes- Number of Participants With Placenta Abruption

Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN

Time frame: 1 day

Maternal Outcomes- Number of Participants With Eclampsia

onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines

Time frame: 20 weeks

Maternal Outcomes- Number of Participants With HELLP Syndrome

group of symptoms that occur in pregnant women who have: hemolysis(H): (the breakdown of red blood cells)elevated liver enzymes (EL). low platelet (LP) count. Assessed by ACOG guidelines and measured in urine and blood samples

Time frame: 4 weeks

Maternal Outcomes- Number of Participants With Postpartum Hemorrhage

excessive bleeding following the birth of a baby

Time frame: 1-24 hrs post delivery

Data from ClinicalTrials.gov

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