LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

Last updated: May 12, 2024
Sponsor: Instituto Nacional de Investigacao em Saude, Angola
Overall Status: Active - Recruiting

Phase

1/2

Condition

Pregnancy Complications

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

Aspirin 100mg

Clinical Study ID

NCT06417411
LEARNER
  • Ages > 15
  • Female

Study Summary

This study is being conducted to evaluate the safety and effect of starting daily use of low dose (100 mg) aspirin in pregnant women with sickle cell disease, who are being followed in two county hospitals in Angola, in the first trimester versus the second trimester of the gestational period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pregnant women with Sickle Cell Disease 15 years old and older
  1. Attending Maternidade Lucrecia Paim, Hospital Materno Infantil Dr. Manuel PedroAzancot de Menezes, or any health commodities in the neighboring area of thereferred hospitals
  1. Willing to attend the regular consultations, and consent to take part in thestudy.

Exclusion

Exclusion Criteria:

  1. Pregnant women with Sickle Cell Disease in the third trimester (after week 27)
  1. HIV infection
  1. Diabetes mellitus
  1. Chronic hypertension
  1. Liver disease measured by laboratory indication being 3 times above the upperlimit of normal
  1. Sickle nephropathy
  1. Multiple pregnancies
  1. Hypersensitivity to aspirin
  1. History of blood transfusion in the last 3 months
  • 10.Those who did not consent to participate in the study.

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: Aspirin 100mg
Phase: 1/2
Study Start date:
March 16, 2024
Estimated Completion Date:
March 16, 2026

Study Description

The proposed project is a prospective, randomized controlled study to evaluate the effects of daily low dose aspirin in pregnant women with Sickle Cell Disease at the first trimester versus the second trimester of the gestation period.

The study will include 450 female participants of all ages, in multiple maternity hospitals in Luanda, Angola, with an official diagnosis of Sickle Cell Disease and confirmed pregnancy. Patients who consent to take part in the study will be given 100 mg aspirin once daily either at the first trimester (6-13 weeks) or the second trimester (14-27 weeks) of the gestation period. Up to 450 participants will be randomly assigned in a 1:1 ratio to the two study treatment trimester groups (225 starting the low dose of aspirin at the first trimester and 225 starting the low dose of aspirin at the second trimester). In both treatment arms, daily use of low dose aspirin will be prescribed/administered until week 36 or time of delivery, whichever comes earlier.

Study Duration:

Each participant will be enrolled in the study for the duration of the pregnancy as follow:

Screening Visit Randomized Treatment Period Follow Up Period (6 weeks postpartum)

Connect with a study center

  • Instituto Nacional de Investigação Em Saúde

    Luanda, 00000
    Angola

    Active - Recruiting

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