LEARNER- Low dosE AspiRiN prEterm tRial (Angola)

Phase 1

Recruiting

• Conditions: Pre-Eclampsia; Sickle Cell Disease; Pregnancy Related; Pregnancy Complications
• Interventions: Drug: Aspirin 100mg

• Registration Number: NCT06417411
• Lead Sponsor: Instituto Nacional de Investigacao em Saude, Angola

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2024-03-16
• Status Verified: 2024-05
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-12
• Last Update Submitted: 2024-05-12
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-03-16
• Study Completion: 2026-03-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin in Second trimester	Aspirin 100mg	Participants who will start the study medication (Aspirin) during the second trimester
Aspirin in First trimester	Aspirin 100mg	Participants who will start the study medication (Aspirin) during the first trimester

Primary Outcome Measures

Name	Time	Method
Maternal Mortality	2 years	Measuring the number of maternal mortalities up to 6 weeks postpartum.
Late Abortion Related Events	2 years	Measuring the number of unintentional abortions late in the pregnancy
Life Birth Related Events	2 years	The number of preterm births will be measured by the number of deliveries before 37 weeks gestational age.

Secondary Outcome Measures

Name	Time	Method
Fetal Mortality Outcomes	2 years	fetal loss due to small gestational age, perinatal mortality, spontaneous abortion, and stillbirth, will be aggregated to quantify the number of fetal mortality events.
Maternal Morbidity	2 years	hypertensive disorders, vaginal bleeding, antepartum hemorrhage, and postpartum hemorrhage, will be aggregated to determine the number of morbidity events related to the mother.
Other Fetal Events	2 years	Early preterm delivery (less than 34 weeks of gestation), extreme preterm delivery (less than 28 weeks of gestation), actual birth weight (measured in grams), post-term delivery (more than 42 weeks of gestation) will be combined to report the number of other fetal related events.

Trial Locations

Locations (1)

Instituto Nacional de Investigação Em Saúde; 🇦🇴 Luanda, Angola