Pre-Eclampsia, Hypertension in Pregnancy, Obesity
Conditions
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.
Interventions
DRUGAspirin 81 mg
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
DRUGAspirin 162 mg
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Outcome- Gestational Age at Delivery | at delivery | — |
| Neonatal Outcomes-Delivery at < 37 Weeks | at delivery | — |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 162 mg/Day Aspirin Aspirin 162 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia | 110 |
| 81 mg/Day Aspirin Aspirin 81 mg: Low dose aspirin was initially reported as having a beneficial effect at preeclampsia | 110 |
| Total | 220 |
Baseline characteristics
| Characteristic | 81 mg/Day Aspirin | Total | 162 mg/Day Aspirin |
|---|---|---|---|
| Age, Continuous | 29 years | 29 years | 30 years |
| Body Mass Index | 38 kg/m^2 | 37.88 kg/m^2 | 37 kg/m^2 |
| Gestational age at enrollment | 15.6 weeks | 15.64 weeks | 15.9 weeks |
| History of preeclampsia in prior pregnancy | 30 Participants | 67 Participants | 37 Participants |
| Insurance Type Government assisted (Medicaid, Medicare or other federal or state funded assistance program) | 99 Participants | 198 Participants | 99 Participants |
| Insurance Type Private | 11 Participants | 21 Participants | 10 Participants |
| Insurance Type Self pay | 0 Participants | 1 Participants | 1 Participants |
| Number of participants diagnosed with gestational diabetes before 20 weeks | 7 Participants | 10 Participants | 3 Participants |
| Number of participants enrolled prior to 16 weeks | 58 Participants | 113 Participants | 55 Participants |
| Number of participants on aspirin prior to enrollment | 21 Participants | 44 Participants | 23 Participants |
| Number of Participants who are Nulliparous | 27 Participants | 46 Participants | 19 Participants |
| Number of Participants who use tobacco during pregnancy | 1 Participants | 3 Participants | 2 Participants |
| Number of Participants with Systemic Lupus Erythematosus | 1 Participants | 3 Participants | 2 Participants |
| Number of participants with Type 1 diabetes | 5 Participants | 8 Participants | 3 Participants |
| Number of participants with type 2 diabetes | 43 Participants | 84 Participants | 41 Participants |
| Race/Ethnicity, Customized African American | 59 Participants | 111 Participants | 52 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 25 Participants | 59 Participants | 34 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 19 Participants | 35 Participants | 16 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 15 Participants | 8 Participants |
| Region of Enrollment United States | 110 participants | 220 participants | 110 participants |
| Sex: Female, Male Female | 110 Participants | 220 Participants | 110 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 110 |
| other Total, other adverse events | 51 / 110 | 61 / 110 |
| serious Total, serious adverse events | 24 / 110 | 19 / 110 |
Outcome results
Primary
Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis
based on American College Obstetrics and Gynecology (ACOG) guidelines
Time frame: 3-7 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis | 37 Participants |
| 81 mg/Day Aspirin | Number of Participants With Preeclampsia Diagnosis With Severe Features Based on Clinician Diagnosis | 41 Participants |
Secondary
Maternal Outcomes- Number of Participants That Required Blood Transfusion
peripartum
Time frame: during delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes- Number of Participants That Required Blood Transfusion | 8 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes- Number of Participants That Required Blood Transfusion | 6 Participants |
Secondary
Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features
Time frame: less than 37 weeks gestational age (GA)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features | 22 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes- Number of Participants Who Delivered Due to Preeclampsia With Severe Features | 21 Participants |
Secondary
Maternal Outcomes- Number of Participants With Eclampsia
onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines
Time frame: 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Eclampsia | 0 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Eclampsia | 0 Participants |
Secondary
Maternal Outcomes-Number of Participants With Gestational Hypertension
development of hypertension anytime during pregnancy based on ACOG guidelines
Time frame: 3-7 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes-Number of Participants With Gestational Hypertension | 13 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes-Number of Participants With Gestational Hypertension | 20 Participants |
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
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes- Number of Participants With HELLP Syndrome | 0 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes- Number of Participants With HELLP Syndrome | 0 Participants |
Secondary
Maternal Outcomes- Number of Participants With Other Maternal Bleeding
any other bleeding associated with birth not otherwise categorized
Time frame: during labor to 24 hrs post delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Other Maternal Bleeding | 0 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Other Maternal Bleeding | 0 Participants |
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
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Placenta Abruption | 3 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Placenta Abruption | 3 Participants |
Secondary
Maternal Outcomes- Number of Participants With Postpartum Hemorrhage
excessive bleeding following the birth of a baby
Time frame: 1-24 hrs post delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Postpartum Hemorrhage | 11 Participants |
| 81 mg/Day Aspirin | Maternal Outcomes- Number of Participants With Postpartum Hemorrhage | 9 Participants |
Secondary
Neonatal Outcome- Gestational Age at Delivery
Time frame: at delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcome- Gestational Age at Delivery | 36.30 weeks |
| 81 mg/Day Aspirin | Neonatal Outcome- Gestational Age at Delivery | 37.20 weeks |
Secondary
Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay | 10 days |
| 81 mg/Day Aspirin | Neonatal Outcome-Neonatal Intensive Care Unit (NICU) Length of Stay | 10.5 days |
Secondary
Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia
chronic lung disease that affects newborns (mostly premature) and infants.
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia | 0 Participants |
| 81 mg/Day Aspirin | Neonatal Outcome-Number of Participants With Bronchopulmonary Dysplasia | 0 Participants |
Secondary
Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV
bleeding inside or around the ventricles in the brain.
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV | 0 Participants |
| 81 mg/Day Aspirin | Neonatal Outcome- Number of Participants With Intraventricular Hemorrhage Grade III-IV | 0 Participants |
Secondary
Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis
medical condition where a portion of the bowel dies
Time frame: from birth until discharge from NICU (about 1 to 4 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis | 1 Participants |
| 81 mg/Day Aspirin | Neonatal Outcome-Number of Participants With Necrotizing Enterocolitis | 0 Participants |
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.
Time frame: 5 minutes post delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcomes-Apgar Score < 5 at 5 Minutes | 4 Participants |
| 81 mg/Day Aspirin | Neonatal Outcomes-Apgar Score < 5 at 5 Minutes | 3 Participants |
Secondary
Neonatal Outcomes-Delivery at < 37 Weeks
Time frame: at delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcomes-Delivery at < 37 Weeks | 58 Participants |
| 81 mg/Day Aspirin | Neonatal Outcomes-Delivery at < 37 Weeks | 45 Participants |
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.
Time frame: at delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 162 mg/Day Aspirin | Neonatal Outcome-Small for Gestational Age | 7 Participants |
| 81 mg/Day Aspirin | Neonatal Outcome-Small for Gestational Age | 3 Participants |