This is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (VIA) who have Type 3 transformation zone (TZ) and randomized to receive either Misoprostol or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
420
Participants will receive placebo (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).
Participants will receive 600 mcg misoprostol (3 tablets) administered vaginally 2-3 hours and 4-6 hours prior to visual inspection with acetic acid (VIA).
Cameroon Baptist Convention Health Core, EtougEbe Baptist Hospital Yaoundé
Yaoundé, Center Region, Cameroon
RECRUITINGConversion rate from Type 3 transformation zone (TZ) to Types 1 or 2
The rate of participants with successful transformation from Type 3 (TZ) to Type 1 or 2 (TZ) will be calculated. It is the number of participants who successfully transformed from Type 3 TZ to Type 1 or 2 TZ, divided by the total number of participants in the entire randomized cohort.
Time frame: Approximately 2-3 hours and approximately 4-6 hours since drug administration
Comparison of the rate of patients converted from Type 3 TZ to Type 1 or 2 TZ between 2-3 hours and 4-6 hours
The rate of transformation from Type 3 transformation zone (TZ) to Type 1 or 2 TZ between 2-3 hours and 4-6 hours after administering misoprostol will be compared. The rate is calculated as the number of successful transformations within each time period (2-3 hours or 4-6 hours) divided by the total cohort.
Time frame: Approximately 2-3 hours vs approximately 4-6 hours
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