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

Phase 2

Completed

• Conditions: Hypertension in Pregnancy; Obesity; Pre-Eclampsia
• Interventions: Drug: Aspirin 81 mg; Drug: Aspirin 162 mg

• Registration Number: NCT03961360
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-16
• Study Start: 2019-05-06
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Status Verified: 2024-04
• Results First Submitted: 2024-04-10
• Results First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Results First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
81 mg/day Aspirin	Aspirin 81 mg	-
162 mg/day Aspirin	Aspirin 162 mg	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis	3-7 months	based on American College Obstetrics and Gynecology (ACOG) guidelines

Secondary Outcome Measures

Name	Time	Method
Neonatal Outcomes-Delivery at < 37 Weeks	at delivery
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	development of hypertension anytime during pregnancy based on ACOG guidelines
Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia	from birth until discharge from NICU (about 1 to 4 weeks)	chronic lung disease that affects newborns (mostly premature) and infants.
Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis	from birth until discharge from NICU (about 1 to 4 weeks)	medical condition where a portion of the bowel dies
Maternal Outcomes- Number of Participants With Postpartum Hemorrhage	1-24 hrs post delivery	excessive bleeding following the birth of a baby
Maternal Outcomes- Number of Participants With Other Maternal Bleeding	during labor to 24 hrs post delivery	any other bleeding associated with birth not otherwise categorized
Maternal Outcomes- Number of Participants That Required Blood Transfusion	during delivery	peripartum
Maternal Outcomes- Number of Participants With Placenta Abruption	1 day	Placental abruption occurs when the placenta separates from the inner wall of the uterus before birth. As assessed by treating OBGYN
Maternal Outcomes- Number of Participants With Eclampsia	20 weeks	onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines
Maternal Outcomes- Number of Participants With HELLP Syndrome	4 weeks	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
Neonatal Outcome- Gestational Age at Delivery	at delivery
Neonatal Outcome-Small for Gestational Age	at delivery	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.
Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay	from birth until discharge from NICU (about 1 to 4 weeks)
Neonatal Outcomes-Apgar Score < 5 at 5 Minutes	5 minutes post delivery	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.
Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV	from birth until discharge from NICU (about 1 to 4 weeks)	bleeding inside or around the ventricles in the brain.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States