Aspirin for Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women

Study Overview
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Brief Summary
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Preeclampsia is a pregnancy-specific syndrome that affects 3 - 5% of pregnancies. It is one of the main causes of maternal, fetal and neonatal morbidity and mortality, resulting in approximately 40,000 maternal deaths worldwide each year. Fortunately, preeclampsia-related deaths have been reduced remarkably in recent decades thanks to improvements in antenatal care and therapeutic interventions, and prophylactic use of low-dose aspirin in women who are at a higher risk of developing preeclampsia. Effective prevention is rarely available for obstetric complications. Aspirin is one of them. Several meta-analyses456 suggested that aspirin prescription reduced the risk of preeclampsia and fetal growth restriction by 40-50% in an aspirin-dose-response pattern.

Detailed Description
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Preterm preeclampsia is an important cause of maternal and perinatal death and complications. It is uncertain whether the intake of low-dose aspirin during pregnancy reduces the risk of preterm preeclampsia. In a meta-analysis of individual-participant data from the trials, the effect of aspirin was not affected by the gestational age at the onset of therapy. In contrast, other meta-analyses showed that aspirin started at or before 16 weeks of gestation resulted in halving the rates of preeclampsia, fetal growth restriction, and perinatal death, whereas aspirin started after 16 weeks of gestation did not have a significant benefit. In addition, the beneficial effect of aspirin that was started at or before 16 weeks of gestation was dose-dependent, with a greater reduction in the incidence of preeclampsia being associated with a daily dose of aspirin of 100 mg or more. This will be a randomized control trial to estimate the efficacy of two doses (81 mg versus 162 mg) of aspirin for prevention of preeclampsia in healthy, nulliparous obese and overweight pregnant women identified in the first trimester.

Official Title
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Comparison of Two Doses (81 mg Versus 162 mg) of Aspirin for the Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women: A Randomized Controlled Trial

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Aspirin 162 mg
* Drug: Aspirin 81 mg
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy, nulliparous obese and overweight pregnant women identified in the first trimester. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a randomized control trial to estimate the efficacy of two doses (81 mg versus 162 mg) of aspirin for prevention of preeclampsia in healthy, nulliparous obese and overweight pregnant women identified in the first trimester.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin 162 mg<br>Aspirin 81mg tow tablet once a day from recruitment until 37 weeks or labor whichever comes first | Drug: Aspirin 162 mg<br>* Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first<br>* Other names: Active Comparator;|
| Active Comparator: Aspirin 81 mg plus placebo<br>Aspirin 81mg one 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<br>* placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first<br>* Other names: Active Comparator;Drug: placebo<br>* placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With early onset 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With preeclampsia between 37 and 41 | The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy | 6 months | 
| 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. | 6 months | 
| The number of cases of preterm birth | The number of cases delivered before 37 weeks gestation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, low dose aspirin, high risk pregnancy