Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417411
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-02
Brief Title:
LEARNER- Low dosE AspiRiN prEterm tRial Angola
Sponsor:
Instituto Nacional de Investigacao em Saude Angola
Organization:
Instituto Nacional de Investigacao em Saude Angola
Study Overview
Official Title:
A Prospective Randomized Controlled Study to Evaluate the Effects of Daily Low Dose Aspirin in Pregnant Women With Sickle Cell Disease When Initiated at the First Trimester Versus the Second Trimester of the Gestational Period
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEARNER
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 11 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 prescribedadministered 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
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 11 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 prescribedadministered 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None