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

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ClinicalTrials.gov Identifier: NCT03725891
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

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.


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

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.


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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 (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 (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 162 mg) of Aspirin for the Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women: A Randomized Controlled Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin 162 mg
Aspirin 81mg tow 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 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
placebo 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: Active Comparator




Primary Outcome Measures :
  1. Number of Participants With early onset 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. Number of Participants With 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



Information from the National Library of Medicine

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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:   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.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT03725891


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

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

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03725891     History of Changes
Other Study ID Numbers: aswu/196/7/18
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

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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:
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Aspirin
Overweight
Pre-Eclampsia
Body Weight
Signs and Symptoms
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