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出境医 / 临床实验 / Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida (ASPREO)
Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida (ASPREO)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pre-Eclampsia Hypertension in Pregnancy Obesity | Drug: Aspirin 81 mg Drug: Aspirin 162 mg | Phase 2 Phase 3 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 220 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | May 6, 2019 |
| Estimated Primary Completion Date : | May 1, 2020 |
| Estimated Study Completion Date : | May 1, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: 162 mg/day Aspirin |
Drug: Aspirin 162 mg
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
|
| Active Comparator: 81 mg/day Aspirin |
Drug: Aspirin 81 mg
Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
|
Outcome Measures
Primary Outcome Measures :
- Preeclampsia diagnosis [ Time Frame: 3-7 months ]based on American College Obstetrics and Gynecology (ACOG) guidelines
Secondary Outcome Measures :
- Maternal Outcomes-Incidence of preterm preeclampsia [ Time Frame: less than 37 weeks gestational age (GA) ]
- Maternal Outcomes-Gestational Hypertension [ Time Frame: 3-7 months ]development of hypertension anytime during pregnancy based on ACOG guidelines
- Maternal Outcomes-Placenta Abruption [ Time Frame: 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-Eclampsia [ Time Frame: 20 weeks ]onset of seizures (convulsions) in a woman with pre-eclampsia per ACOG guidelines
- Maternal Outcomes-HELLP syndrome [ Time Frame: 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-Postpartum Hemorrhage [ Time Frame: 1-24 hrs post delivery ]excessive bleeding following the birth of a baby
- Maternal Outcomes-Other maternal bleeding [ Time Frame: during labor to 24 hrs post delivery ]any other bleeding associated with birth not otherwise categorized
- Maternal Outcomes-Need for blood transfusion [ Time Frame: during delivery ]peripartum
- Neonatal Outcomes- Gestational age at delivery [ Time Frame: at delivery ]
- Neonatal Outcomes-Delivery at < 37 weeks [ Time Frame: at delivery ]
- Neonatal Outcomes-Apgar score at 5 min ≤ 5 [ Time Frame: 5 min post delivery ]A method to quickly summarize the health of newborn children against infant mortality Appearance, Pulse, Grimace, Activity, and Respiration. Scored from 0-10
- Neonatal Outcomes-Small for gestational age [ Time Frame: at delivery ]
- Neonatal Outcomes-Neonatal Intensive Care Unit (NICU) length of stay [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]
- Neonatal Outcomes-Intraventricular Hemorrhage Grade III-IV [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]bleeding inside or around the ventricles in the brain.
- Neonatal Outcomes-Bronchopulmonary Dysplasia [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]chronic lung disease that affects newborns (mostly premature) and infants.
- Neonatal Outcomes-Necrotizing Enterocolitis [ Time Frame: from birth until discharge from NICU (about 1 to 10 weeks) ]medical condition where a portion of the bowel dies
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Farah Amro, MD | 713-500-6421 | farah.h.amro@uth.tmc.edu |
Locations
| United States, Texas | |
| The University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Farah H Amro, MD 713-500-6421 farah.h.amro@uth.tmc.edu | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
| Principal Investigator: | farah Amro, MD | University of Texas Health Science Center of Houston |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 16, 2019 | ||||||
| First Posted Date ICMJE | May 23, 2019 | ||||||
| Last Update Posted Date | May 23, 2019 | ||||||
| Actual Study Start Date ICMJE | May 6, 2019 | ||||||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Preeclampsia diagnosis [ Time Frame: 3-7 months ] based on American College Obstetrics and Gynecology (ACOG) guidelines
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida | ||||||
| Official Title ICMJE | Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida: An Open Label, Comparative Effectiveness, Randomized Controlled Trial (ASPREO Trial) | ||||||
| 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 Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE |
220 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | May 1, 2020 | ||||||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria
OR 2. At least stage I hypertension during pregnancy
OR 3. Pre-gestational diabetes
Exclusion Criteria
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03961360 | ||||||
| Other Study ID Numbers ICMJE | HSC-MS-18-1073 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Farah Hassan Amro, The University of Texas Health Science Center, Houston | ||||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | The University of Texas Health Science Center, Houston | ||||||
| Verification Date | May 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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