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Phase 3 N=220 Randomized Treatment

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

Pre-Eclampsia · Hypertension in Pregnancy · Obesity

Enrolled (actual)
220
Serious AEs
19.6%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis — 37; 41 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Aspirin 81 mg (Drug); Aspirin 162 mg (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
The University of Texas Health Science Center, Houston
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis
37; 41
SECONDARY
Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features
22; 21
SECONDARY
Maternal Outcomes-Number of Participants With Gestational Hypertension
13; 20
SECONDARY
Maternal Outcomes- Number of Participants With Placenta Abruption
3; 3
SECONDARY
Maternal Outcomes- Number of Participants With Eclampsia
0; 0
SECONDARY
Maternal Outcomes- Number of Participants With HELLP Syndrome
0; 0
SECONDARY
Maternal Outcomes- Number of Participants With Postpartum Hemorrhage
11; 9
SECONDARY
Maternal Outcomes- Number of Participants With Other Maternal Bleeding
0; 0
SECONDARY
Maternal Outcomes- Number of Participants That Required Blood Transfusion
8; 6
SECONDARY
Neonatal Outcome- Gestational Age at Delivery
36.30; 37.20
SECONDARY
Neonatal Outcomes-Delivery at < 37 Weeks
58; 45
SECONDARY
Neonatal Outcomes-Apgar Score < 5 at 5 Minutes
4; 3
SECONDARY
Neonatal Outcome-Small for Gestational Age
7; 3
SECONDARY
Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay
10; 10.5
SECONDARY
Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV
0; 0
SECONDARY
Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia
0; 0
SECONDARY
Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis
1; 0

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.

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:
  • 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

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03961360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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