Pre-EclampsiaNCT06261203
Low Dose Aspirin for Prevention of Early Pregnancy Loss
A study testing Aspirin in people with Pre-Eclampsia, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 15 Jul 2025
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Before 8 weeks gestation
- Women at high risk of preeclampsia according to Royal College of Obstetricians and Gynecologists (RCOG) (Robson et al., 2013):
- Maternal age ≥ 35 years.
- Nulliparity.
- BMI ≥ 30 kg/m2.
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- Smoking of r ≥ 10 cigarettes per day.
- Previous history of small for gestational age (SGA) baby.
- Previous history of stillbirth.
- Pregnancy interval < 6 months or ≥ 60months.
- Chronic hypertension.
- Diabetes with vascular disease.
- Willingness to participate in the study and provide informed written consent.
Who cannot join
- Known allergy or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Use of any anticoagulant medication (e.g., heparin, warfarin, clopidogrel)
- Use of low-dose aspirin for any indication prior to the current pregnancy
- Chronic use of NSAIDs or corticosteroids
- History of bleeding disorder or active bleeding
- Any medical condition that may contraindicate the use of low-dose aspirin (e.g., peptic ulcer disease, asthma, liver, or kidney disease)
- Multiple gestation
- Inability to provide informed consent or comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit University hospitals
Asyut, Assuit
Mohamed Nagy, Lecturer, 01096655458, drmnagy@aun.edu.eg
Abdelrahman Mahmoud, Assist.Prof.
About this study
Official title: Low Dose Aspirin for Prevention of Early Pregnancy Loss in Women at High Risk of Preeclampsia
Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.
The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries
Read the detailed description
The pathogenesis of preeclampsia (PE) is not fully understood, but it is believed to be associated with impaired early placental development, primarily attributed to defective trophoblast invasion and remodeling of the spiral arterioles .
Various mechanisms have been proposed to contribute to the development of preeclampsia, including angiogenesis, endothelial injury, oxidative stress, and inflammation, which lead to clinical manifestations such as hypertension, proteinuria, and end organ damage .
Preeclampsia is associated with severe short- and long-term maternal and neonatal morbidities, and its occurrence is influenced by risk factors such as diabetes, hypertension, multifetal gestation, as well as the severity and timing of previous preeclampsia episodes .
While low-dose aspirin (LDA) has shown some benefit in preventing preeclampsia and fetal growth restriction when initiated before 16 weeks' gestation, there is no widely effective prophylactic therapy, and delivery remains the primary approach to prevent maternal morbidity and mortality.
Recent research has indicated that LDA intervention, following firsttrimester screening of women at risk of developing preeclampsia, can significantly reduce the occurrence of preterm PE .
As such, LDA's use is increasingly considered standard practice for women at high risk of developing preeclampsia .
Nevertheless, the potential role of low-dose aspirin in preventing early pregnancy loss in this specific high-risk population remains underexplored. Given that abnormal placentation and inflammation are associated with both early and late pregnancy losses, low-dose aspirin therapy has the potential to mitigate these complications.
However, current evidence on aspirin's efficacy in preventing early pregnancy loss is limited. Considering this, we propose a randomized, double-blind, placebocontrolled trial to investigate whether low-dose aspirin (81 mg daily) administered before 16 weeks of gestation can effectively reduce the rate of early pregnancy loss in women at high risk of developing preeclampsia.
- Conditions
- Pre-Eclampsia
- Being tested
- Aspirin
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Low Dose Asprin
To investigate the efficacy of low dose aspirin for prevention of early pregnancy loss in women at high risk of preeclampsia.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Experimental Group) | Experimental | About 125 Participants in the treatment group will receive 81 mg low-dose aspirin once daily starting from the time of enrollment and continuing until the end of pregnancy Receives: Drug: Aspirin |
| Group B (Control Group) | Placebo comparator | About 125 Participants will receive only the routine care of pregnancy until the end of pregnancy Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of pregnancy loss
To investigate the efficacy of low dose aspirin (81 mg) for prevention of early pregnancy loss in women at high risk of preeclampsia.
Measured: From base line to the end of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies 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
- The The study's findings have the potential to clarify aspirin's role in preventing adverse pregnancy outcomes related to placental dysfunction and improve the management of women at risk of placental-mediated complications.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamad Sayed, Professor, Study chair, Assiut University, Faculty of medicine, Assuit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261203
- Sponsor's protocol ID
- Hany Hosny
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Aspirin for Prevention of Early Pregnancy Loss in Women at High Risk of Preeclampsia
- ClinicalTrials.gov ID
- NCT06261203
- Acronym / sponsor ID
- Hany Hosny
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 15 Feb 2024 (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, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.
The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries
Detailed description
The pathogenesis of preeclampsia (PE) is not fully understood, but it is believed to be associated with impaired early placental development, primarily attributed to defective trophoblast invasion and remodeling of the spiral arterioles .
Various mechanisms have been proposed to contribute to the development of preeclampsia, including angiogenesis, endothelial injury, oxidative stress, and inflammation, which lead to clinical manifestations such as hypertension, proteinuria, and end organ damage .
Preeclampsia is associated with severe short- and long-term maternal and neonatal morbidities, and its occurrence is influenced by risk factors such as diabetes, hypertension, multifetal gestation, as well as the severity and timing of previous preeclampsia episodes .
While low-dose aspirin (LDA) has shown some benefit in preventing preeclampsia and fetal growth restriction when initiated before 16 weeks' gestation, there is no widely effective prophylactic therapy, and delivery remains the primary approach to prevent maternal morbidity and mortality.
Recent research has indicated that LDA intervention, following firsttrimester screening of women at risk of developing preeclampsia, can significantly reduce the occurrence of preterm PE .
As such, LDA's use is increasingly considered standard practice for women at high risk of developing preeclampsia .
Nevertheless, the potential role of low-dose aspirin in preventing early pregnancy loss in this specific high-risk population remains underexplored. Given that abnormal placentation and inflammation are associated with both early and late pregnancy losses, low-dose aspirin therapy has the potential to mitigate these complications.
However, current evidence on aspirin's efficacy in preventing early pregnancy loss is limited. Considering this, we propose a randomized, double-blind, placebocontrolled trial to investigate whether low-dose aspirin (81 mg daily) administered before 16 weeks of gestation can effectively reduce the rate of early pregnancy loss in women at high risk of developing preeclampsia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The The study's findings have the potential to clarify aspirin's role in preventing adverse pregnancy outcomes related to placental dysfunction and improve the management of women at risk of placental-mediated complications.
| Arm | Type | Receives |
|---|---|---|
| Group A (Experimental Group) | Experimental | Drug: AspirinAbout 125 Participants in the treatment group will receive 81 mg low-dose aspirin once daily starting from the time of enrollment and continuing until the end of pregnancy |
| Group B (Control Group) | Placebo comparator | Drug: AspirinAbout 125 Participants will receive only the routine care of pregnancy until the end of pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Singleton pregnancy
- Before 8 weeks gestation
- Women at high risk of preeclampsia according to Royal College of Obstetricians and Gynecologists (RCOG) (Robson et al., 2013):
- Maternal age ≥ 35 years.
- Nulliparity.
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Use of any anticoagulant medication (e.g., heparin, warfarin, clopidogrel)
- Use of low-dose aspirin for any indication prior to the current pregnancy
- Chronic use of NSAIDs or corticosteroids
- History of bleeding disorder or active bleeding
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 |
|---|---|---|
| AspirinAlso: Low Dose AsprinTo investigate the efficacy of low dose aspirin for prevention of early pregnancy loss in women at high risk of preeclampsia. | Drug | Group A (Experimental Group), Group B (Control Group) |
Primary outcome
Prevention of pregnancy loss
Time frame: From base line to the end of pregnancy
To investigate the efficacy of low dose aspirin (81 mg) for prevention of early pregnancy loss in women at high risk of preeclampsia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pre-Eclampsia
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Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Mohamad Sayed, Professor study chair
Assiut University, Faculty of medicine, Assuit.
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 in people with Pre-Eclampsia, run by Egymedicalpedia 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 13 inclusion and 8 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 15 Feb 2024. 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. Some participants in this study may receive a placebo. 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 Hosny, Resident (01274580828, hanyhosny123@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of pregnancy loss (time frame: From base line to the end of pregnancy). 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 15 Feb 2024.