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Sulphadoxine/Pyrimethamine and Proguanil for malaria prophylaxis in Sickle Cell pregnancy: A Randomized Controlled Trial (SPICKLE TRIAL)

Sulphadoxine/Pyrimethamine and Proguanil for malaria prophylaxis in Sickle Cell pregnancy: A Randomized Controlled Trial (SPICKLE TRIAL)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201802003063273
Enrollment
248
Registered
2018-02-07
Start date
2021-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

SP Group Sulphadoxine Pyrimethamine arm
P group Proguanil arm

Sponsors

EDCTP
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: ¿ Pregnant women of all gravidity confirmed as having HbSS genotype. ¿ Screened after 16 weeks or onset of quickening, both aparasitaemic and parasitaemic at first enrolment. ¿ Must give informed written consent.

Exclusion criteria

Exclusion criteria: ¿ Known adverse drug reaction to any of the two medications (Sulphadoxine/Pyrimethamine and Proguanil). ¿ Co-existing medical disorders that may alter immunity such as diabetes mellitus (DM) and human immunodeficiency virus infection (HIV). ¿ Multiple gestations. ¿ Presence of severe clinical malaria at booking. ¿ Less than 16 weeks gestational age for Sulphadoxine/Pyrimethamine (SP) group. ¿ Use of antimalarials within the last one week prior to booking. ¿ Refusal to give informed written consent.

Design outcomes

Primary

MeasureTime frame
incidence of malaria parasite at delivery

Secondary

MeasureTime frame
incidence of clinical malaria, incidence of malaria complications such as worsening maternal anaemia (haemoglobin concentration <10g/dl) and low birth weight (<2500g), adherence to medications and incidence of adverse drug events.

Countries

Nigeria

Contacts

Public ContactOchuwa A. Babah

Senior Lecturer Consultant Obstetrician and Gynaecologist College of Medicine University of Lagos Lagos University Teaching Hospital Idi Araba Lagos Nigeria

ochuwab@yahoo.co.uk+2348023591137

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026