PreeclampsiaNCT03725891
Aspirin for Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women
A study testing Aspirin 162 mg and Aspirin 81 mg in people with Preeclampsia, run by Aswan University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Aspirin 162 mg and Aspirin 81 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- healthy, nulliparous obese and overweight pregnant women identified in the first trimester.
- Give written informed consent.
Who cannot join
- Multiple gestations,
- fetal aneuploidy
- major fetal structural anomaly
- bleeding disorder
- allergy to aspirin
- women already on aspirin or heparin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, m, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
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
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Aspirin 162 mg, Aspirin 81 mg, placebo
- Keywords
- preeclampsia, low dose aspirin, high risk pregnancy
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 162 mgDrug
Also called Active Comparator
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Aspirin 81 mgDrug
Also called Active Comparator
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
placeboDrug
Also called Active Comparator
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
| Study group | Role | What they receive |
|---|---|---|
| Aspirin 162 mg | Active comparator | Aspirin 81mg tow tablet once a day from recruitment until 37 weeks or labor whichever comes first Receives: Drug: Aspirin 162 mg |
| Aspirin 81 mg plus placebo | Active comparator | 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 Receives: Drug: Aspirin 81 mg; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 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.
Measured: 6 months
The number of cases of preterm birth
The number of cases delivered before 37 weeks gestation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Dec 2018
- Primary completion30 Nov 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725891
- Sponsor's protocol ID
- aswu/196/7/18
- Status last verified
- Jan 2019
- First submitted
- 29 Oct 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03725891
- Acronym / sponsor ID
- aswu/196/7/18
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, low dose aspirin, high risk pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aspirin 162 mg | Active comparator | Drug: Aspirin 162 mgAspirin 81mg tow tablet once a day from recruitment until 37 weeks or labor whichever comes first |
| Aspirin 81 mg plus placebo | Active comparator | Drug: Aspirin 81 mg, Drug: placeboAspirin 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy, nulliparous obese and overweight pregnant women identified in the first trimester.
- Give written informed consent.
Key exclusion criteria (6 listed)
- Multiple gestations,
- fetal aneuploidy
- major fetal structural anomaly
- bleeding disorder
- allergy to aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 162 mgAlso: Active ComparatorAspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first | Drug | Aspirin 162 mg |
| Aspirin 81 mgAlso: Active Comparatorplacebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first | Drug | Aspirin 81 mg plus placebo |
| placeboAlso: Active Comparatorplacebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first | Drug | Aspirin 81 mg plus placebo |
Primary outcome
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
3 secondary outcomes
Number of Participants With preeclampsia between 37 and 41
Time frame: 6 months
The number of cases of Fetal Growth Restriction
Time frame: 6 months
The number of cases of preterm birth
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hany f sallam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin 162 mg and Aspirin 81 mg in people with Preeclampsia, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hany f sallam, md (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With early onset Preeclampsia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.