PreeclampsiaPhase 4NCT07779057
Comparison of High- Versus Low-Dose Aspirin for Pregnancy Outcomes in Women at High Risk of Preeclampsia
A Phase 4 study testing Aspirin in people with Preeclampsia, run by Medicare Hospital (Pvt) Limited at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia. The main question the study aims to answer is: 1. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 12 May 2026to 11 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Gestational age 11-14 weeks
- High risk of preeclampsia
Who cannot join
- Active gastritis
- Abnormal coagulation profile (INR > 1.5)
- Renal disease
- Platelet count < 150,000/mm^3
- Fetal malformations
- Vaginal bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Medicare Hospital (Pvt) Ltd.
Multan, Punjab Province, 60000
Fiza A Principal Investigator, MBBS, +92 336 6005416, fiza.arshad66@gmail.com
Samee A Professor, FRCOG, +92 300 8637070, sameeakhtar54@gmail.com
About this study
Official title: High Versus Low Dose Aspirin Effects on Fetomaternal Outcomes in Women With High Risk of Preeclampsia
The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia.
The main question the study aims to answer is:
Read more
- Does taking 150 mg of aspirin reduce the occurrence of preeclampsia more effectively than taking 75 mg of aspirin in pregnant women at high risk of preeclampsia?
- Are there differences in stillbirth and newborn birth weight between the two aspirin doses?
The study will include 224 pregnant women aged 18-45 years who are between 11 and 14 weeks of pregnancy and are identified as being at high risk for preeclampsia. Participants will be randomly assigned to one of two groups.
- Participants in the low-dose group will take 75 mg of aspirin once daily at bedtime.
- Participants in the high-dose group will take 150 mg of aspirin once daily at bedtime.
Participants will continue their assigned aspirin dose until 36 weeks of pregnancy and will be followed every 2 weeks until delivery.
The study will record whether participants develop preeclampsia and whether stillbirth occurs. The birth weight of each newborn will also be measured within 3 hours of birth.
The study hypothesis is that 150 mg of aspirin will result in a lower incidence of preeclampsia than 75 mg of aspirin in pregnant women at high risk of preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- Aspirin
- Keywords
- Aspirin, Birth weight, Pregnancy, Preeclampsia, Stillbirth
- Medical subject headings
- Pre-Eclampsia, Birth Weight, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy.
AspirinDrug
Aspirin 150 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Aspirin | Active comparator | Participants will be given low-dose aspirin Receives: Drug: Aspirin |
| High-dose Aspirin | Experimental | Participants will be given high-dose aspirin Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Preeclampsia
Proportion of participants who develop preeclampsia after 20 weeks of pregnancy and before delivery. Preeclampsia will be diagnosed if the patient has proteins excreted in urine (24-hour urine protein >300 mg or urinary protein to creatinine ratio ≥ 0.3 or dipstick 2+) and persistent high blood pressure ≥ 140/90 mmHg for minimum of 4 hours or ≥160/110 mmHg),
Measured: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation
Secondary outcomes (1)
Stillbirth
Proportion of pregnancies resulting in stillbirth. Stillbirth will be defined as delivery of baby with no signs of life.
Measured: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start12 May 2026
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2026 (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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicare Hospital (Pvt) Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fiza Arshad, Medicare Hospital (Pvt) Limited
- Investigators
- Samee A Professor, FRCOG, Study chair, Medicare Hospital (Pvt) Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779057
- Sponsor's protocol ID
- UAN1111-1345-3668
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Dose Aspirin Effects on Fetomaternal Outcomes in Women With High Risk of Preeclampsia
- ClinicalTrials.gov ID
- NCT07779057
- Acronym / sponsor ID
- UAN1111-1345-3668
- Conditions
- Preeclampsia
- Keywords
- Aspirin, Birth weight, Pregnancy, Preeclampsia, Stillbirth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medicare Hospital (Pvt) LimitedUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2026 (estimated)
- First posted
- 21 Aug 2026 (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.
The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia.
The main question the study aims to answer is:
- Does taking 150 mg of aspirin reduce the occurrence of preeclampsia more effectively than taking 75 mg of aspirin in pregnant women at high risk of preeclampsia?
- Are there differences in stillbirth and newborn birth weight between the two aspirin doses?
The study will include 224 pregnant women aged 18-45 years who are between 11 and 14 weeks of pregnancy and are identified as being at high risk for preeclampsia. Participants will be randomly assigned to one of two groups.
- Participants in the low-dose group will take 75 mg of aspirin once daily at bedtime.
- Participants in the high-dose group will take 150 mg of aspirin once daily at bedtime.
Participants will continue their assigned aspirin dose until 36 weeks of pregnancy and will be followed every 2 weeks until delivery.
The study will record whether participants develop preeclampsia and whether stillbirth occurs. The birth weight of each newborn will also be measured within 3 hours of birth.
The study hypothesis is that 150 mg of aspirin will result in a lower incidence of preeclampsia than 75 mg of aspirin in pregnant women at high risk of preeclampsia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose Aspirin | Active comparator | Drug: AspirinParticipants will be given low-dose aspirin |
| High-dose Aspirin | Experimental | Drug: AspirinParticipants will be given high-dose aspirin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Gestational age 11-14 weeks
- High risk of preeclampsia
Key exclusion criteria (6 listed)
- Active gastritis
- Abnormal coagulation profile (INR > 1.5)
- Renal disease
- Platelet count < 150,000/mm^3
- Fetal malformations
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 |
|---|---|---|
| AspirinAspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy. | Drug | Low-dose Aspirin |
| AspirinAspirin 150 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy | Drug | High-dose Aspirin |
Primary outcome
Incidence of Preeclampsia
Time frame: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation
Proportion of participants who develop preeclampsia after 20 weeks of pregnancy and before delivery. Preeclampsia will be diagnosed if the patient has proteins excreted in urine (24-hour urine protein >300 mg or urinary protein to creatinine ratio ≥ 0.3 or dipstick 2+) and persistent high blood pressure ≥ 140/90 mmHg for minimum of 4 hours or ≥160/110 mmHg),
1 secondary outcome
Stillbirth
Time frame: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
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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
RecruitingObservational study
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.
Samee A Professor, FRCOG study chair
Medicare Hospital (Pvt) Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Preeclampsia, run by Medicare Hospital (Pvt) Limited at 1 site in Pakistan.
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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiza A Principal Investigator, MBBS (+92 336 6005416, fiza.arshad66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Preeclampsia (time frame: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation). 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 21 Aug 2026.