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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

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03725891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • 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
  • 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.
  • The number of cases of preterm birth [ Time Frame: 6 months ]
    The number of cases delivered before 37 weeks gestation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin for Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Preeclampsia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Aspirin 162 mg
    Aspirin 81mg tow tablet once a day from recruitment until 37 weeks or labor whichever comes first
    Intervention: Drug: Aspirin 162 mg
  • 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
    Interventions:
    • Drug: Aspirin 81 mg
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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.
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03725891
Other Study ID Numbers  ICMJE aswu/196/7/18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party hany farouk, Aswan University Hospital
Study Sponsor  ICMJE Aswan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: hany f sallam, md Aswan University Hospital
PRS Account Aswan University Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP