PreeclampsiaNCT07852585
Comparison of Pregnancy Outcomes in Primigravida Receiving Low-Dose Aspirin for the Prevention of Preeclampsia.
A study testing Low-dose aspirin and No-Aspirin in people with Preeclampsia, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Local data on the effectiveness of low-dose aspirin in high-risk primigravida are limited. The present study was planned to compare pregnancy outcomes between high-risk primigravida receiving low-dose aspirin (75 mg/day) from 12 weeks of gestation and those not receiving aspirin. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Low-dose aspirin and No-Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 30 Jun 2026
- 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
- Primigravida women
- High-risk pregnancy
- Aged 18-40 years
- Singleton pregnancy
- Gestational age ≤12 weeks
Who cannot join
- Women with pre-existing chronic hypertension
- Renal disease
- Diabetes mellitus
- Autoimmune disease
- Bleeding disorders
- Hypersensitivity to aspirin
- History of peptic ulcer disease
- Those using aspirin or other antiplatelet drugs
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahawal Victoria Hospital/Quaid-e-Azam Medical College
Bahawalpur, Punjab Province, 63100
About this study
Official title: Low-Dose Aspirin: A Game-Changer in Preventing Pre-Eclampsia and Adverse Pregnancy Outcomes in Primigravida
Local data on the effectiveness of low-dose aspirin in high-risk primigravida are limited. The present study was planned to compare pregnancy outcomes between high-risk primigravida receiving low-dose aspirin (75 mg/day) from 12 weeks of gestation and those not receiving aspirin.
Read the detailed description
Despite strong international evidence supporting low-dose aspirin for the prevention of preeclampsia, its use remains inconsistent in many developing countries, and evidence from local populations is limited. Further evaluation of its effectiveness among high-risk primigravida women may help inform appropriate clinical use and contribute to reducing adverse maternal and neonatal outcomes associated with preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- Low-dose aspirin, No-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.
Low-dose aspirinDrug
Participants received low-dose aspirin (75 mg) once daily, starting at 12 weeks of gestation and continuing until 36 weeks of gestation or delivery, along with standard care.
No-AspirinOther
Participants received standard antenatal care without aspirin.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin-Group | Experimental | Participants received low-dose aspirin (75 mg) once daily, starting at 12 weeks of gestation and continuing until 36 weeks of gestation or delivery, along with standard care. Receives: Drug: Low-dose aspirin; Other: No-Aspirin |
| No-Aspirin-Group | Experimental | Participants received standard antenatal care without aspirin. Receives: Other: No-Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia
The frequency of patients developing preeclampsia as new-onset hypertension after 20 weeks of gestation was noted.
Measured: After 24 weeks of the enrollment
Placental abruption
The frequency of patients with placental abruption.
Measured: After 24 weeks of the enrollment
Preterm birth
The frequency of neonates born before 37 completed weeks was noted.
Measured: At birth, after 24 weeks of the enrollment
Low-birth-weight
The frequency of low-birth-weight neonates, defined as a birth weight<2.5 kg, was noted.
Measured: At birth, after 24 weeks of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Aug 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
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
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Shamsun Nisa, FCPS, Principal investigator, Bahawal Victoria Hospital/Quaid-e-Azam Medical College Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852585
- Sponsor's protocol ID
- Dr-Shamsa-QAMC
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Aspirin: A Game-Changer in Preventing Pre-Eclampsia and Adverse Pregnancy Outcomes in Primigravida
- ClinicalTrials.gov ID
- NCT07852585
- Acronym / sponsor ID
- Dr-Shamsa-QAMC
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 1 Oct 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.
Local data on the effectiveness of low-dose aspirin in high-risk primigravida are limited. The present study was planned to compare pregnancy outcomes between high-risk primigravida receiving low-dose aspirin (75 mg/day) from 12 weeks of gestation and those not receiving aspirin.
Detailed description
Despite strong international evidence supporting low-dose aspirin for the prevention of preeclampsia, its use remains inconsistent in many developing countries, and evidence from local populations is limited. Further evaluation of its effectiveness among high-risk primigravida women may help inform appropriate clinical use and contribute to reducing adverse maternal and neonatal outcomes associated with preeclampsia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin-Group | Experimental | Drug: Low-dose aspirin, Other: No-AspirinParticipants received low-dose aspirin (75 mg) once daily, starting at 12 weeks of gestation and continuing until 36 weeks of gestation or delivery, along with standard care. |
| No-Aspirin-Group | Experimental | Other: No-AspirinParticipants received standard antenatal care without aspirin. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primigravida women
- High-risk pregnancy
- Aged 18-40 years
- Singleton pregnancy
- Gestational age ≤12 weeks
Key exclusion criteria (8 listed)
- Women with pre-existing chronic hypertension
- Renal disease
- Diabetes mellitus
- Autoimmune disease
- Bleeding disorders
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 |
|---|---|---|
| Low-dose aspirinParticipants received low-dose aspirin (75 mg) once daily, starting at 12 weeks of gestation and continuing until 36 weeks of gestation or delivery, along with standard care. | Drug | Aspirin-Group |
| No-AspirinParticipants received standard antenatal care without aspirin. | Other | Aspirin-Group, No-Aspirin-Group |
Primary outcome
Preeclampsia
Time frame: After 24 weeks of the enrollment
The frequency of patients developing preeclampsia as new-onset hypertension after 20 weeks of gestation was noted.
Placental abruption
Time frame: After 24 weeks of the enrollment
The frequency of patients with placental abruption.
Preterm birth
Time frame: At birth, after 24 weeks of the enrollment
The frequency of neonates born before 37 completed weeks was noted.
Low-birth-weight
Time frame: At birth, after 24 weeks of the enrollment
The frequency of low-birth-weight neonates, defined as a birth weight<2.5 kg, was noted.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Preeclampsia
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Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk 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. This study is not recruiting at the moment.
Shamsun Nisa, FCPS principal investigator
Bahawal Victoria Hospital/Quaid-e-Azam Medical College Bahawalpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose aspirin and No-Aspirin in people with Preeclampsia, run by Muhammad Aamir Latif 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 5 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: finished, as of the sponsor's last update on 1 Oct 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia (time frame: After 24 weeks of the enrollment). The study lists 4 primary outcomes in all. 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 1 Oct 2026.