F. Amant et al., Misoprostol compared with methylergometrine for the prevention of postpartum haemorrhage: a double-blind randomised trial, BR J OBST G, 106(10), 1999, pp. 1066-1070
Objective To compare the: efficacy and side effects of misoprostol, compare
d with methylergometrine, for the prevention of postpartum haemorrhage.
Design A double-blind, randomised clinical trial of 200 women with apparent
ly normal pregnancies.
Setting University teaching hospital.
Participants Two hundred women with apparently normal pregnancies.
Methods After the baby had been born, all women received two capsules by mo
uth and the contents of an ampule by intravenous injection. Each woman only
received one active product. The capsules contained either a total of 600
mu g misoprostol or placebo, and the ampule 200 mu g of methylergometrine o
r placebo.
Main outcome measures Need for further oxytocic drugs, blood pressure, the
presence of side effects, mean haemoglobin and haematocrit three days after
delivery.
Results Two hundred women completed the study (100 received methylergometri
ne and 100 misoprostol). Postpartum haemorrhage occurred in 4.3% of the met
hylergometrine group and 8.3% of the misoprostol group (P = 0.57). The need
for further oxytocic drugs was 4.4% and 12.8% after methylergometrine and
misoprostol, respectively (P = 0.065). One hour after the birth of the baby
there was no difference in the mean systolic blood pressure (117 +/- 12 mm
Hg versus 115 +/- 11 mmHg) (P = 0.26) or the mean diastolic blood pressure
(72 +/- 10 mmHg versus 71 +/- 11 mmHg for the groups receiving methylergome
trine or misoprostal, respectively) (P = 0.97). The mean temperature in the
misoprostol group rose to 37 degrees C, compared with 37 degrees C in the
methylergometrine group (P < 0.0001). In the misoprostol group 34% develope
d fever (> 38 degrees C) compared with 3% in the methylergometrine group (P
< 0.0001). Shivering (visual analogue score greater than or equal to 8) al
so occurred more often after misoprostol (42%) than after methylergometrine
(8.5%) (P < 0.0001). The haemoglobin level (g/dL) on the third postpartum
day was similar for bath groups (11.0 and 11.2 for methylergometrine and mi
soprostol, respectively) (P = 0.39).
Conclusions This study suggests that although protection from postpartum ha
emorrhage using par enteral methylergometrine and oral misoprostol is nearl
y equal, misoprostol is associated with more side effects.