Recruiting

Low Dose Aspirin for Prevention of Early Pregnancy Loss in Women at High Risk of Preeclampsia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Aspirin

Drug
Who is being recruted

Urogenital Diseases+2

+ Female Urogenital Diseases and Pregnancy Complications

+ Pre-Eclampsia

From 18 to 40 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: July 2023
See protocol details

Summary

Principal SponsorEgymedicalpedia
Study ContactHany Hosny, Resident
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2023

Actual date on which the first participant was enrolled.

This study explores whether taking a low-dose aspirin (81 mg daily) before the 16th week of pregnancy can reduce early pregnancy loss in women who are at high risk of developing preeclampsia. Preeclampsia is a pregnancy complication characterized by high blood pressure and can cause serious health issues for both the mother and the baby. Women with conditions such as diabetes, hypertension, or those expecting multiple babies are more susceptible to this condition. Since preeclampsia is linked to problems with the development of the placenta and inflammation, researchers are interested in seeing if aspirin, which can help with these issues, might also prevent early pregnancy loss. Participants in this study will be randomly assigned to receive either the low-dose aspirin or a placebo, which is a substance with no active medicine, to ensure that the results are unbiased. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the aspirin and who is receiving the placebo, which helps ensure the accuracy of the results. The main focus is to see if taking aspirin reduces the rate of early pregnancy loss among these high-risk women. While aspirin is generally considered safe in low doses, participants will be monitored for any side effects or complications during the study.

Official TitleLow Dose Aspirin for Prevention of Early Pregnancy Loss in Women at High Risk of Preeclampsia
NCT06261203
Principal SponsorEgymedicalpedia
Study ContactHany Hosny, Resident
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPre-EclampsiaPregnancy ComplicationsHypertension, Pregnancy-Induced

Criteria

13 inclusion criteria required to participate
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.

Show More Criteria

8 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
About 125 Participants will receive only the routine care of pregnancy until the end of pregnancy

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Assuit University hospitals

Asyut, EgyptOpen Assuit University hospitals in Google Maps
Recruiting
One Study Center