Aspirin for Prevention of Preeclampsia
Primary Purpose
Preeclampsia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
aspirin 162 mg
aspirin 81 mg
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring preeclampsia, low dose aspirin, high risk pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant women presenting prior to 17+0 weeks' gestation.
- Moderate to high risk of preeclampsia.
- One or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated BMI > 25, and maternal age <20 or >35.
- Give written informed consent.
Exclusion Criteria:
- Multiple gestations,
- fetal aneuploidy
- major fetal structural anomaly
- bleeding disorder
- allergy to aspirin
- women already on aspirin or heparin.
Sites / Locations
- Aswan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
aspirin 162 mg
aspirin 81 mg plus placebo
Arm Description
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first plus placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Outcomes
Primary Outcome Measures
Number of Participants With early Preeclampsia
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300 mg in 24 hrs) before 34 weeks gestation
Secondary Outcome Measures
Prevention of preeclampsia between 37 and 41
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
The number of cases of Fetal Growth Restriction
The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.
The number of cases of preterm birth
The number of cases delivered before 37 weeks gestation
Full Information
NCT ID
NCT03726177
First Posted
October 29, 2018
Last Updated
January 8, 2019
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03726177
Brief Title
Aspirin for Prevention of Preeclampsia
Official Title
Comparison of Two Doses (81 mg Versus 162mg) of Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prophylaxis with low-dose aspirin has been recommended to prevent preeclampsia, the rationale being that hypertension and abnormalities of coagulation in this disease are caused in part by an imbalance between vasodilating and vasoconstricting prostaglandins. Low-dose aspirin therapy inhibits thromboxane production more than prostacyclin production and therefore should protect against vasoconstriction and pathologic blood coagulation in the placenta. Initially, several single-center trials, mostly among women at increased risk for preeclampsia, demonstrated a substantial reduction in the risk of proteinuric hypertension as well as reductions in the incidences of preterm birth, infants small for gestational age, and perinatal death,
Detailed Description
This will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
preeclampsia, low dose aspirin, high risk pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
both participants and researchers will be blinded to the intervention given.
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aspirin 162 mg
Arm Type
Active Comparator
Arm Description
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Arm Title
aspirin 81 mg plus placebo
Arm Type
Active Comparator
Arm Description
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first plus placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Intervention Type
Drug
Intervention Name(s)
aspirin 162 mg
Other Intervention Name(s)
Active Comparator
Intervention Description
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Intervention Type
Drug
Intervention Name(s)
aspirin 81 mg
Other Intervention Name(s)
active comparator
Intervention Description
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Placebo to asprin
Intervention Description
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Primary Outcome Measure Information:
Title
Number of Participants With early Preeclampsia
Description
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300 mg in 24 hrs) before 34 weeks gestation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Prevention of preeclampsia between 37 and 41
Description
The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
Time Frame
6 months
Title
The number of cases of Fetal Growth Restriction
Description
The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.
Time Frame
6 months
Title
The number of cases of preterm birth
Description
The number of cases delivered before 37 weeks gestation
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The population of interest involves women attending the study hospital for antenatal care and delivery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women presenting prior to 17+0 weeks' gestation.
Moderate to high risk of preeclampsia.
One or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated BMI > 25, and maternal age <20 or >35.
Give written informed consent.
Exclusion Criteria:
Multiple gestations,
fetal aneuploidy
major fetal structural anomaly
bleeding disorder
allergy to aspirin
women already on aspirin or heparin.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam, md
Phone
01022336052
Ext
002
Email
hany.farouk@aswu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.ed.eg
First Name & Middle Initial & Last Name & Degree
Nahla w Shady, m
Phone
1019240504
Ext
002
Email
nahla.elsayed@aswu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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Aspirin for Prevention of Preeclampsia
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