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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 162 mg/day Aspirin | Experimental |
| |
| 81 mg/day Aspirin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81 mg | Drug | Low dose aspirin was initially reported as having a beneficial effect at preeclampsia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | development of hypertension anytime during pregnancy based on ACOG guidelines |
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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
OR
3. Pre-gestational diabetes
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| farah Amro, MD | University of Texas Health Science Center of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 162 mg/Day Aspirin | Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia |
| FG001 | 81 mg/Day Aspirin | Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 162 mg/Day Aspirin | Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia |
| BG001 | 81 mg/Day Aspirin | Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis | based on American College Obstetrics and Gynecology (ACOG) guidelines | Posted | Count of Participants | Participants | 3-7 months |
|
From enrollment (12 to 20.6 weeks gestational age) to 6 weeks post-partum
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 162 mg/Day Aspirin | Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Placenta Abruption | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Preeclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Farah Amro, MD | The University of Texas Health Science Center at Houston | 713-500-6421 | farah.h.amro@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2024 | Apr 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin 162 mg | Drug | Low dose aspirin was initially reported as having a beneficial effect at preeclampsia |
|
| 3-7 months |
| 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 |
| Maternal Outcomes- Number of Participants With Eclampsia | onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines | 20 weeks |
| 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 |
| Maternal Outcomes- Number of Participants With Postpartum Hemorrhage | excessive bleeding following the birth of a baby | 1-24 hrs post delivery |
| 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 |
| Maternal Outcomes- Number of Participants That Required Blood Transfusion | peripartum | during delivery |
| Neonatal Outcome- Gestational Age at Delivery | at delivery |
| Neonatal Outcomes-Delivery at < 37 Weeks | at delivery |
| 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 |
| 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 |
| Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay | from birth until discharge from NICU (about 1 to 4 weeks) |
| 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) |
| 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) |
| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insurance Type | Count of Participants | Participants |
|
| Gestational age at enrollment | Median | Inter-Quartile Range | weeks |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Number of Participants who are Nulliparous | Count of Participants | Participants |
|
| Number of Participants with Systemic Lupus Erythematosus | Count of Participants | Participants |
|
| Number of Participants who use tobacco during pregnancy | Count of Participants | Participants |
|
| History of preeclampsia in prior pregnancy | Count of Participants | Participants |
|
| Number of participants with Type 1 diabetes | Count of Participants | Participants |
|
| Number of participants with type 2 diabetes | Count of Participants | Participants |
|
| Number of participants diagnosed with gestational diabetes before 20 weeks | Count of Participants | Participants |
|
| Number of participants enrolled prior to 16 weeks | Count of Participants | Participants |
|
| Number of participants on aspirin prior to enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Maternal Outcomes- Number of Participants With Eclampsia | onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Maternal Outcomes- Number of Participants With Postpartum Hemorrhage | excessive bleeding following the birth of a baby | Posted | Count of Participants | Participants | 1-24 hrs post delivery |
|
|
|
| Secondary | Maternal Outcomes- Number of Participants With Other Maternal Bleeding | any other bleeding associated with birth not otherwise categorized | Posted | Count of Participants | Participants | during labor to 24 hrs post delivery |
|
|
|
| Secondary | Maternal Outcomes- Number of Participants That Required Blood Transfusion | peripartum | Posted | Count of Participants | Participants | during delivery |
|
|
|
| Secondary | Neonatal Outcome- Gestational Age at Delivery | Posted | Median | Inter-Quartile Range | weeks | at delivery |
|
|
|
| Secondary | Neonatal Outcomes-Delivery at < 37 Weeks | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | at delivery |
|
|
|
| Secondary | Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay | Posted | Median | Inter-Quartile Range | days | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | from birth until discharge from NICU (about 1 to 4 weeks) |
|
|
|
| 0 |
| 110 |
| 24 |
| 110 |
| 51 |
| 110 |
| EG001 | 81 mg/Day Aspirin | Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia | 0 | 110 | 19 | 110 | 61 | 110 |
| Postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal blood transfusion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Fetal Heart Defect | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Kidney Malformation | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Necrotizing Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |