Status:
COMPLETED
Low Dose Aspirin for Preventing Intrauterine Growth Restriction and Preeclampsia in Sickle Cell Pregnancy (PIPSICKLE)
Lead Sponsor:
University of Lagos, Nigeria
Conditions:
Intrauterine Growth Restriction
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Pregnancy in sickle cell disease (SCD) is fraught with many complications including preeclampsia (PE) and intrauterine growth restriction (IUGR). Previously, the investigators found an abnormality in ...
Detailed Description
STUDY RATIONALE Sickle cell disease (SCD) especially in pregnancy poses great burden and is thus designated a global public health problem by World Health Organization (WHO) and United Nations. In Nig...
Eligibility Criteria
Inclusion
- Age 18 years and above
- Singleton fetus
- Women whose genotypes are Haemoglobin SS or SC.
- 28 weeks gestation or less at recruitment, estimated from the last menstrual period or by an early ultrasound scan.
Exclusion
- Women with associated medical conditions in pregnancy e.g., HIV infection, diabetes mellitus, hypertension, renal disease, sickle nephropathy
- Multiple pregnancy
- Hypersensitivity to aspirin
- History of blood transfusion in the last 3 months
- Women who participated in the PIPSICKLE trial during their previous pregnancy.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2024
Estimated Enrollment :
476 Patients enrolled
Trial Details
Trial ID
NCT05253781
Start Date
July 1 2020
End Date
November 21 2024
Last Update
January 9 2025
Active Locations (16)
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1
Ajeromi General Hospital, Ajegunle, Lagos State
Ajegunle, Lagos, Nigeria
2
Federal Medical Centre, Ebute Metta, Lagos State
Ebute-Metta, Lagos, Nigeria
3
Lagos University Teaching Hospital
Idi Araba, Lagos, Nigeria, 100254
4
Alimosho General Hospital, Igando, Lagos State
Igando, Lagos, Nigeria