Clinical trial NCT03961360: Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
Official title: Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pre-Eclampsia
Hypertension in Pregnancy
Obesity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis
timeFrame: 3-7 months
Secondary outcomes:
measure: Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features
timeFrame: less than 37 weeks gestational age (GA)
measure: Maternal Outcomes-Number of Participants With Gestational Hypertension
timeFrame: 3-7 months
measure: Maternal Outcomes- Number of Participants With Placenta Abruption
timeFrame: 1 day
measure: Maternal Outcomes- Number of Participants With Eclampsia
timeFrame: 20 weeks
measure: Maternal Outcomes- Number of Participants With HELLP Syndrome
timeFrame: 4 weeks
measure: Maternal Outcomes- Number of Participants With Postpartum Hemorrhage
timeFrame: 1-24 hrs post delivery
measure: Maternal Outcomes- Number of Participants With Other Maternal Bleeding
timeFrame: during labor to 24 hrs post delivery
measure: Maternal Outcomes- Number of Participants That Required Blood Transfusion
timeFrame: during delivery
measure: Neonatal Outcome- Gestational Age at Delivery
timeFrame: at delivery
measure: Neonatal Outcomes-Delivery at < 37 Weeks
timeFrame: at delivery
measure: Neonatal Outcomes-Apgar Score < 5 at 5 Minutes
timeFrame: 5 minutes post delivery
measure: Neonatal Outcome-Small for Gestational Age
timeFrame: at delivery
measure: Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay
timeFrame: from birth until discharge from NICU (about 1 to 4 weeks)
measure: Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV
timeFrame: from birth until discharge from NICU (about 1 to 4 weeks)
measure: Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia
timeFrame: from birth until discharge from NICU (about 1 to 4 weeks)
measure: Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis
timeFrame: from birth until discharge from NICU (about 1 to 4 weeks)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: University of Texas Health Science Center of Houston
name: farah Amro, MD
role: PRINCIPAL_INVESTIGATOR
References: