Clinical trial NCT03725891: Aspirin for Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia
Keywords: preeclampsia
low dose aspirin
high risk pregnancy
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With early onset Preeclampsia
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With preeclampsia between 37 and 41
timeFrame: 6 months
measure: The number of cases of Fetal Growth Restriction
timeFrame: 6 months
measure: The number of cases of preterm birth
timeFrame: 6 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: