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

NCT03961360 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HSC-MS-18-1073
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  based on American College Obstetrics and Gynecology (ACOG) guidelines

  3-7 months

Secondary Outcomes (16)

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

  less than 37 weeks gestational age (GA)

• Maternal Outcomes-Number of Participants With Gestational Hypertension

  3-7 months

• Maternal Outcomes- Number of Participants With Placenta Abruption

  1 day

• Maternal Outcomes- Number of Participants With Eclampsia

  20 weeks

• Maternal Outcomes- Number of Participants With HELLP Syndrome

  4 weeks

Study Arms (2)

162 mg/day Aspirin

EXPERIMENTAL

Drug: Aspirin 162 mg

81 mg/day Aspirin

ACTIVE COMPARATOR

Drug: Aspirin 81 mg

Interventions

Aspirin 81 mg DRUG

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

81 mg/day Aspirin

Aspirin 162 mg DRUG

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

162 mg/day Aspirin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• \. 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
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Obesity

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Farah Amro, MD
• Organization: The University of Texas Health Science Center at Houston

farah.h.amro@uth.tmc.edu

713-500-6421

Study Officials

• farah Amro, MD

  University of Texas Health Science Center of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow OBGYN

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 23, 2019
• Study Start: May 6, 2019
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: May 8, 2024
• Results First Posted: May 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)