Aspirin for Prevention of Preeclampsia

Sponsor

Aswan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03726177

Collaborator

(none)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Dec 1, 2018

Anticipated Primary Completion Date :

Nov 30, 2020

Anticipated Study Completion Date :

Jan 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 Names: 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 Names: active comparator Drug: placebo placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first Other Names: Placebo to asprin

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 Names:

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 Names:

active comparator

Drug: placebo

placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Other Names:

Placebo to asprin

Outcome Measures

Primary Outcome Measures

Number of Participants With early Preeclampsia [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

Prevention of preeclampsia between 37 and 41 [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 [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 [6 months]
The number of cases delivered before 37 weeks gestation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Aswan University	Aswan		Egypt	81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hany farouk, Principal Investigator, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT03726177

Other Study ID Numbers:

aswu 194/7/18

First Posted:

Oct 31, 2018

Last Update Posted:

Jan 10, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by hany farouk, Principal Investigator, Aswan University Hospital

preeclampsia

low dose aspirin

high risk pregnancy

Additional relevant MeSH terms:

Pre-Eclampsia

Aspirin

Study Results

No Results Posted as of Jan 10, 2019