This study will evaluate side effects after sublingual misoprostol (600 mcg) as a first-line treatment for primary postpartum hemorrhage (PPH) due to suspected uterine atony.
The study purpose is to confirm whether a lower, 600 mcg dose of sublingual misoprostol will reduce the incidence of elevated body temperature (≥40°C) associated with misoprostol. The study will compare the incidence of high fevers following treatment with 600 mcg sublingual misoprostol to previously documented rates using 800 mcg sublingual misoprostol. An additional line of research is to investigate whether some women are more susceptible to experiencing high fevers following misoprostol administration, and whether genetic factors are responsible for misoprostol-induced fevers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
600 mcg of sublingual misoprostol
Hospital Gineco Obstetrico Isidro Ayora
Quito, Pichincha, Ecuador
Rate of fever above 40.0 degrees centigrade
% of women with body temperature measures ≥40°C
Time frame: Body temperature measured at 60 minutes and 90 minutes post-treatment with misoprostol for PPH
Side effect profile of misoprostol for PPH treatment
% of women experiencing any shivering and any fever or any other side effect
Time frame: Side effects observed for 3 hours post-treatment with misoprostol for PPH
Acceptability of side effect profile among women
% of women who rate side effects as acceptable, neutral, unacceptable, don't know
Time frame: Women interviewed prior to hospital discharge about acceptability of side effects (24 hours postpartum)
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