Phase 3
N=220
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
Pre-Eclampsia · Hypertension in Pregnancy · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03961360 ↗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
| Outcome | Result | p-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
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.