Aspirin for Prevention of Preeclampsia
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ClinicalTrials.gov Identifier: NCT03726177 |
Recruitment Status : Unknown
Verified January 2019 by hany farouk, Aswan University Hospital.
Recruitment status was: Recruiting
First Posted : October 31, 2018
Last Update Posted : January 10, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preeclampsia | Drug: aspirin 162 mg Drug: aspirin 81 mg Drug: placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | both participants and researchers will be blinded to the intervention given. |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | December 1, 2018 |
Estimated Primary Completion Date : | November 30, 2020 |
Estimated Study Completion Date : | January 1, 2021 |
Arm | Intervention/treatment |
---|---|
Active Comparator: aspirin 162 mg
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
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Drug: aspirin 162 mg
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Other Name: Active Comparator |
Active Comparator: aspirin 81 mg plus placebo
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
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Drug: aspirin 81 mg
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Other Name: active comparator Drug: placebo placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Other Name: Placebo to asprin |
- Number of Participants With early Preeclampsia [ Time Frame: 6 months ]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
- Prevention of preeclampsia between 37 and 41 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]The number of cases delivered before 37 weeks gestation

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | The population of interest involves women attending the study hospital for antenatal care and delivery |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726177
Contact: hany f sallam, md | 01022336052 ext 002 | hany.farouk@aswu.edu.eg |
Egypt | |
Aswan University | Recruiting |
Aswan, Egypt, 81528 | |
Contact: hany f sallam, md 01092440504 ext 002 nahla.elsayed@aswu.ed.eg | |
Contact: Nahla w Shady, m 1019240504 ext 002 nahla.elsayed@aswu.edu.eg |
Principal Investigator: | hany f sallam, md | Aswan University Hospital |
Responsible Party: | hany farouk, Principal Investigator, Aswan University Hospital |
ClinicalTrials.gov Identifier: | NCT03726177 |
Other Study ID Numbers: |
aswu 194/7/18 |
First Posted: | October 31, 2018 Key Record Dates |
Last Update Posted: | January 10, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
preeclampsia low dose aspirin high risk pregnancy |
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