ClinicalTrials.gg
RecruitingNCT07779057Updated Aug 21, 2026

Comparison of High- Versus Low-Dose Aspirin for Pregnancy Outcomes in Women at High Risk of Preeclampsia

A Phase 4 interventional study of Aspirin and Aspirin in Preeclampsia, sponsored by Medicare Hospital (Pvt) Limited. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Medicare Hospital (Pvt) Limited · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2026, registered Aug 2026).
  • Started May 2026; still recruiting 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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?
  2. 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.

02

Conditions studied

  • Preeclampsia

Keywords

  • Aspirin
  • Birth weight
  • Pregnancy
  • Preeclampsia
  • Stillbirth
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 60 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Medicare Hospital (Pvt) Limited is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gestational age 11-14 weeks
  • High risk of preeclampsia

Exclusion criteria

Exclusion Criteria:

  • Active gastritis
  • Abnormal coagulation profile ( > 1.5)
  • Renal disease
  • count \< 150,000/mm\^3
  • Fetal malformations
  • Vaginal bleeding
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Low-dose Aspirin

    Participants will be given low-dose aspirin

    Drug: Aspirin

  • Experimental
    High-dose Aspirin

    Participants will be given high-dose aspirin

    Drug: Aspirin

Interventions

  • Aspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy.

  • Aspirin 150 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy

06

What researchers measure

Primary outcomes

  1. 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),

    Time frame: 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.

    Time frame: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation

Other outcomes

  1. Neonatal Birth Weight

    Birth weight of the newborn measured in grams using a digital weighing scale within 3 hours of birth.

    Time frame: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation

07

Study locations

1 of 1 sites recruiting
  • Medicare Hospital (Pvt) Ltd.
    Multan, Punjab Province 60000, Pakistan
    Recruiting
    • Fiza A Principal Investigator, MBBS · Contactfiza.arshad66@gmail.com · +92 336 6005416
    • Samee A Professor, FRCOG · Contactsameeakhtar54@gmail.com · +92 300 8637070
    • Fiza A Principal Investigator, MBBS · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Nov 2026, 5 months after the start.

Of 35 phase 4 interventional studies under Pre-Eclampsia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 35. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Aug 21, 2026
StartActual
May 12, 2026
Primary completionEst.
Nov 11, 2026
CompletionEst.
Nov 11, 2026
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07779057
Lead sponsor
Medicare Hospital (Pvt) Limited
Responsible party
Dr. Fiza Arshad (Principal Investigator, Medicare Hospital (Pvt) Limited) — Principal investigator
First posted
Aug 21, 2026
Start date
May 12, 2026
Primary completion
Nov 11, 2026 (estimated)
Completion
Nov 11, 2026 (estimated)
Last update
Aug 21, 2026

Study contacts

Fiza A Principal Investigator, MBBS
Contact
fiza.arshad66@gmail.com
+92 336 6005416
Samee A Professor, FRCOG
Contact
sameeakhtar54@gmail.com
+92 300 8637070
Samee A Professor, FRCOG
study chair · Medicare Hospital (Pvt) Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Aspirin

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