Low Dose Aspirin for Prevention of Early Pregnancy Loss

NCT06261203 | Recruiting DMC

• 1 other identifier: Hany Hosny
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• 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.

  From base line to the end of pregnancy

Study Arms (2)

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

Drug: Aspirin

Group B (Control Group)

PLACEBO COMPARATOR

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

Drug: Aspirin

Interventions

Aspirin DRUG

To investigate the efficacy of low dose aspirin for prevention of early pregnancy loss in women at high risk of preeclampsia.

Also known as: Low Dose Asprin

Group A (Experimental Group); Group B (Control Group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Assuit University hospitals

Asyut, Assuit, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mohamad Sayed, Professor

  Assiut University, Faculty of medicine, Assuit.

  STUDY CHAIR

Central Study Contacts

Hany Hosny, Resident

CONTACT

01274580828; hanyhosny123@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 15, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

EG (1)