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

Obesity Clinical Trial

— ASPREO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961360
• Other study ID #: HSC-MS-18-1073
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 6, 2019
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Obesity
• Pre-Eclampsia

Intervention

Drug:
• Aspirin 81 mg
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
• Aspirin 162 mg
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features		less than 37 weeks gestational age (GA)
Secondary	Maternal Outcomes-Number of Participants With Gestational Hypertension	development of hypertension anytime during pregnancy based on ACOG guidelines	3-7 months
Secondary	Maternal Outcomes- Number of Participants With Placenta Abruption	Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN	1 day
Secondary	Maternal Outcomes- Number of Participants With Eclampsia	onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines	20 weeks
Secondary	Maternal Outcomes- Number of Participants With HELLP Syndrome	group of symptoms that occur in pregnant women who have: hemolysis(H): (the breakdown of red blood cells)elevated liver enzymes (EL). low platelet (LP) count. Assessed by ACOG guidelines and measured in urine and blood samples	4 weeks
Secondary	Maternal Outcomes- Number of Participants With Postpartum Hemorrhage	excessive bleeding following the birth of a baby	1-24 hrs post delivery
Secondary	Maternal Outcomes- Number of Participants With Other Maternal Bleeding	any other bleeding associated with birth not otherwise categorized	during labor to 24 hrs post delivery
Secondary	Maternal Outcomes- Number of Participants That Required Blood Transfusion	peripartum	during delivery
Secondary	Neonatal Outcome- Gestational Age at Delivery		at delivery
Secondary	Neonatal Outcomes-Delivery at < 37 Weeks		at delivery
Secondary	Neonatal Outcomes-Apgar Score < 5 at 5 Minutes	The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.	5 minutes post delivery
Secondary	Neonatal Outcome-Small for Gestational Age	Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile.	at delivery
Secondary	Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay		from birth until discharge from NICU (about 1 to 4 weeks)
Secondary	Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV	bleeding inside or around the ventricles in the brain.	from birth until discharge from NICU (about 1 to 4 weeks)
Secondary	Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia	chronic lung disease that affects newborns (mostly premature) and infants.	from birth until discharge from NICU (about 1 to 4 weeks)
Secondary	Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis	medical condition where a portion of the bowel dies	from birth until discharge from NICU (about 1 to 4 weeks)