COMPARATIVE EFFECTIVENESS OF 200µG VERSUS 400µG OF SUBLINGUAL MISOPROSTOL FOR THE PREVENTION OF POSTPARTUM HAEMORRHAGE (PPH): A RANDOMISED CONTROLLED TRIAL

Abstract

Objectives
To compare the effectiveness of 200µg with that of 400µg of misoprostol for the
prevention of postpartum haemorrhage in the third stage of labour.
Methods
One hundred and twenty four eligible parturient in active phase of labour or who had
induction of labour when vaginal delivery was anticipated were randomised to receive either
200µg or 400µg of sublingual misoprostol. The main outcome measures were: amount of
blood loss during delivery, occurrence of primary postpartum haemorrhage which is defined
as blood loss of 500ml or more, difference in packed cell volume, need for additional
uterotonics and side effects profile. Associations between variables were tested by Chi
Square test and student t-test. Relative risks were calculated for side effects. A p-value of less
than 0.05 was considered to be statistically significant.
Result
A total of 124 women received random assignments. Demographic, antepartum and
intrapartum characteristics were similar between the groups. There were no significant
differences between the groups in total blood loss 1 hour post delivery (P=0.679), occurrence
of PPH (P=0.752), need for additional uterotonics (P=0.803) and difference in packed cell
volume (P=0.572). There was however, a lower incidence of shivering and fever with use of
200µg than 400µg of misoprostol (19.4% versus 58.1%. p< 0.001. RR 0.33; 95% CI 0.192
0.570) and ( 8.1% versus 17.7% P=0.180; RR 0.45; 95% CI 0.168-1.232), respectively.
Conclusion
On the basis of the present study, 200µg of misoprostol taken sublingually is well
tolerated, safe and as effective as 400µg in the routine management of the third stage of
labour. Incidences of side effects were lower with 200µg and the drug has the advantages of
lower cost. Clinical applications of low doses of sublingual misoprostol for the prevention of
PPH should be further explored by larger randomised trials.