Low Dose Aspirin for Preterm Preeclampsia Prevention - a Randomized Trial of 81 Vs 162 Mg/day Dose in High-risk Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The impact of 81mg/day vs 162 mg/day aspirin on S-FLT
研究概览
简要总结
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily acetylsalicylic acid (ASA) use. Based on screening results, patients will be randomized as outlined below into one of four groups. The proposed study is a pilot to determine if the higher dose of ASA has positive impacts on measures that predict preeclampsia, compared to the lower dose. If positive findings, data from this study could be used to develop a larger trial powered to determine if the higher ASA dose can improve clinical outcomes.
详细描述
This will be a randomized, open-label, controlled trial of patients at high risk of developing preeclampsia examining 81 mg/day vs 162mg/day daily ASA use. Currently, all patients that present to UVA Obstetric clinics are evaluated for development of preeclampsia per the current ACOG guidelines. If they screen positive per ACOG guidelines, then it is recommended they initiate 81mg/day ASA starting at 12 weeks of pregnancy and continuing until delivery. For this study, patients that present for early first trimester ultrasound (US) (for dating and/or genetic testing + ultrasound) will be offered enrollment in the study, and consenting patients will undergo double screening tests with ACOG and the FMF-based preeclampsia screen. This test will include first trimester uterine artery PI, assessment of maternal blood pressure, a maternal history and maternal serum markers including PAPP-A, PLGF, S-FLT, AFP. The first trimester preeclampsia screen will be performed between 10 weeks, 0 days and 13 weeks, 6 days of pregnancy.
For the patients within the intervention group, repeat uterine artery PI measurements will be performed during the patient's 20-week anatomic survey ultrasound. Repeat maternal serum biomarkers will be collected with routine 28-week labs and at time of delivery (standard times for blood draws in pregnancy) for all enrolled patients. Patients will be followed longitudinally through their pregnancy and delivery and neonatal outcomes will be recorded. Delivery and timing of delivery will be based solely on obstetric indications regardless of status in the trial. All uterine artery Doppler measurements will be obtained by P.J. Kumar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Ages 18-50
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Pregnant female in the first trimester.
- •Ability to take oral medication and be willing to adhere to the aspirin regimen
- •Patient has a prenatal ultrasound between 11+0 through 13+6 days of gestation
- •Patient who has low or high risks for preeclampsia by the ACOG (American College of Obstetricians and Gynecologists) screening tool, and low or high risks for the FMF prescreening tool for preeclampsia.
排除标准
- •ASA allergy, known hypersensitivity to NSAIDS
- •Patients with nasal polyps
- •Patients with aspirin-induced asthma exacerbations
- •Active peptic ulcer disease
- •Severe hepatic dysfunction
- •History of GI bleeding
- •Pregnancy with major abnormalities demonstrated on the 11-13-week scan
- •Patient presents beyond 13w6d for first prenatal visit
- •Age < 18
- •Non-viable pregnancy
研究组 & 干预措施
2 Randomized Group 1
Group 2: These patients will be screened negative for the ACOG screening test but positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.
干预措施: Aspirin 81Mg Ec Tab (Drug)
2 Randomized Group 1
Group 2: These patients will be screened negative for the ACOG screening test but positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.
干预措施: Aspirin 162Mg Ec Tab (Drug)
3 Standard of Care Group
Group 3: These patients will be screened positive for the ACOG screening test but negative for the FMF preeclampsia screen. These women will be offered 81 mg aspirin, which is the standard of care.
干预措施: Aspirin 81Mg Ec Tab (Drug)
Group 4 Randomized Group 2
Group 4: These patients will be screened negative for the ACOG screening test and positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.
干预措施: Aspirin 81Mg Ec Tab (Drug)
Group 4 Randomized Group 2
Group 4: These patients will be screened negative for the ACOG screening test and positive for the FMF preeclampsia screen. These women will be randomized to either 81mg or 162 mg aspirin.
干预措施: Aspirin 162Mg Ec Tab (Drug)
结局指标
主要结局
The impact of 81mg/day vs 162 mg/day aspirin on S-FLT
时间窗: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of S-FLT in pregnancy. Unit of measure is multiples of the median (MoM).
The impact of 81mg/day vs 162 mg/day aspirin on AFP (alpha fetal protein)
时间窗: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of AFP in pregnancy. Unit of measure is multiples of the median (MoM).
The impact of 81mg/day vs 162 mg/day aspirin on PAPP-A
时间窗: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of PAPP-A in pregnancy. Unit of measure is multiples of the median (MoM).
The impact of 81mg/day vs 162 mg/day aspirin on PGLF (Placenta growth factor)
时间窗: from before 14 weeks gestation age through delivery (up to 41 weeks gestation)
To assess the effect of 81mg/day vs 162mg/day on the progression of PGLF in pregnancy. Unit of measure is multiples of the median (MoM).
次要结局
- The impact of 81 mg/day vs 162 mg/day aspirin on fetal outcomes(from before 14 weeks gestation age through discharge from hospital following delivery (up to 6 weeks post birth))
- The impact of 81 mg/day vs 162 mg/day aspirin dosage on Uterine artery pulsatility average in patients with 81 vs 162 mg/day of ASA(from before 14 weeks gestation age through delivery (up to 41 weeks gestation))
- The impact of 81 mg/day vs 162 mg/day aspirin on maternal outcomes(from before 14 weeks gestation age through delivery and resolution of any pregnancy and delivery-related illnesses (up to 6 weeks postpartum))
研究者
Christopher S. Ennen
Principal Investigator
University of Virginia