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The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia

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ClinicalTrials.gov Identifier: NCT03735433
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kara M Rood, MD, Ohio State University

Tracking Information
First Submitted Date  ICMJE November 4, 2018
First Posted Date  ICMJE November 8, 2018
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
Incidence of Diagnosis of preeclampsia [ Time Frame: Through study completion, an average for 10 months ]
by acog definitions
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
preeclampsia [ Time Frame: Through study completion, an average for 10 months ]
by acog definitions
Change History Complete list of historical versions of study NCT03735433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
Incidence of aspirin resistance based on incomplete inhibition of TBx2 [ Time Frame: Through study completion, an average for 10 months ]
incomplete platelet inhibition measured by urinary TBx2
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
aspirin resistance [ Time Frame: Through study completion, an average for 10 months ]
incomplete platelet inhibition measured by urinary TBx2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Two Aspirin Dosing Strategies for Obese Women at High Risk for Preeclampsia
Official Title  ICMJE The Effect of 81mg vs 162mg ASA for Preeclampsia Prevention in Obese Women at High Risk for Developing Preeclampsia
Brief Summary Low dose aspirin (LDA) is used for preeclampsia (PE) prevention in high risk women, but the precise mechanism and optimal dose is not known. Evidence in the non-obstetric literature suggests AR may be more common among patients with a high body mass index (BMI). Recent unpublished data showed that LDA substantially lowers TxB2 levels regardless of BMI, but rates of complete platelet inhibition are lower in women with BMI ≥40. This data suggests that higher doses of ASA may be necessary in obese women. Therefore we plan determine if use of 162mg compared to the traditional 81mg ASA decreased rates of preeclampsia in women considered high risk for developing preclampsia.
Detailed Description Evidence suggests that an imbalance in prostacyclin and thromboxane A2 (TxA2) plays a key role in PE. Aspirin (ASA) has a dose-dependent effect blocking production of TxA2, a potent stimulator of platelet aggregation (PA) and promoter of vasoconstriction. Incomplete inhibition of PA, designated aspirin resistance (AR), can be reduced by increasing the ASA dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Preeclampsia
Intervention  ICMJE Drug: 162mg aspirin dose
2 pills of 81mg aspirin
Study Arms  ICMJE
  • No Intervention: 81 mg daily aspirin dose
    obese women >30 BMI at risk for preeclampsia will receive recommended 81mg ASA
  • Active Comparator: 162mg daily aspirin dose
    obese women >30 BMI at risk for preeclampsia will receive increased dose of 162mg ASA
    Intervention: Drug: 162mg aspirin dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI at enrollment >/= 30
  • plan for ASA for preeclampsia prevention

Exclusion Criteria:

  • BMI < 30
  • already on ASA
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnant women
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03735433
Other Study ID Numbers  ICMJE OBASA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kara M Rood, MD, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP