Aspirin for Prevention of Preeclampsia

• ClinicalTrials.gov Identifier: NCT03726177
• Recruitment Status: Recruiting
• First Posted: October 31, 2018
• Last Update Posted: January 10, 2019
• Sponsor: Aswan University Hospital
• Information provided by (Responsible Party): hany farouk, Aswan University Hospital

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,

Condition or disease	Intervention/treatment	Phase
Preeclampsia	Drug: aspirin 162 mg; Drug: aspirin 81 mg; Drug: placebo	Not Applicable

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.

Study Design

• 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

Arms and Interventions

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	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	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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. The number of cases of preterm birth [ Time Frame: 6 months ]
   The number of cases delivered before 37 weeks gestation

Eligibility Criteria

• 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

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.

Contacts and Locations

Contacts

Contact: hany f sallam, md; 01022336052 ext 002; hany.farouk@aswu.edu.eg

Locations

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

Sponsors and Collaborators

Aswan University Hospital

Investigators

• Principal Investigator: hany f sallam, md; Aswan University Hospital

More Information

• 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
• 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

Keywords provided by hany farouk, Aswan University Hospital:

preeclampsia; low dose aspirin; high risk pregnancy

Additional relevant MeSH terms:

Aspirin; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics