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

NCT ID: NCT03961360

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2023-04-10

Brief Summary

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.

Conditions

Pre-Eclampsia; Hypertension in Pregnancy; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

162 mg/day Aspirin

Group Type: EXPERIMENTAL

Aspirin 162 mg

Intervention Type: DRUG

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

81 mg/day Aspirin

Group Type: ACTIVE_COMPARATOR

Aspirin 81 mg

Intervention Type: DRUG

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

Interventions

Aspirin 81 mg

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

Intervention Type: DRUG

Aspirin 162 mg

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Farah Hassan Amro

Clinical Fellow OBGYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

farah Amro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center of Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-18-1073

Identifier Type: -

Identifier Source: org_study_id