Randomised controlled trial of sublingual and vaginal
administration of misoprostol for medical
abortion up to 13 weeks gestation
H. Hamoda, P.W. Ashok, G.M.M. Flett, A. Templeton
Department of Obstetrics & Gynaecology, University of
Aberdeen, UK
Objectives: To assess women’s acceptability, side
effects and effectiveness of sublingual versus vaginal administration of
misoprostol
for medical abortion up to 13 weeks gestation.
Design & Methods: The primary outcome of the study
was patients’ acceptability. Women requesting medical abortion up to 13
weeks gestation at a Scottish Teaching Hospital were asked to participate.
Mifepristone (200mg) was given orally followed by
misoprostol (sublingual: 600mg, vaginal: 800mg) 36–48 hours later. A further
dose of 400mg was given three hours later (sublingually
or vaginally). Women between 9 and 13 weeks gestation received a further dose of
400mg (sublingually or vaginally),
three hours later if abortion had not occurred.
Results: A total of 339 women were recruited. Of these,
171 were in the sublingual group and 168 in the vaginal group. The
mean (SD) age and gestation of women was 24.2 (6.5) years and 24.2 (5.7) years;
and 67 (13.3) days and 66 (13.5) days in the
sublingual and vaginal groups, respectively (p=0.99 and 0.58, respectively).
Complete abortion without the need for surgical
evacuation occurred in 156 (98.1%) women and 153 (97.5%) in the sublingual and
vaginal groups, respectively (p=0.69). The
number of misoprostol doses used was 1.9 (1.0) and 1.8 (0.8) and the mean (SD)
induction to abortion interval was 4.49 (3.1)
hours and 4.54 (5.1), respectively (p=0.35 and 0.84, respectively). There was no
significant difference in nausea (p=0.61),
vomiting (p=0.13), tiredness (p=0.92), headache (p=0.92), hot flushes (p=0.72)
or dizziness (p=0.61) between the two groups;
nor was there a difference in analgesia requirements between the two groups
(p=0.26). Women receiving sublingual misoprostol
were more likely to experience diarrhoea (P=0.002), shivering (p=0.0001) and
unpleasant mouth taste (P=0.0001). A total 70%
of women in the sublingual group expressed satisfaction; 18% answered ‘Don’t
know’; while 12% were dissatisfied, compared to
68%; 28%; and 4%, respectively in the vaginal group (p=0.01).
Conclusions: This study shows that the sublingual route
of misoprostol administration for medical abortion up to 13 weeks
gestation is effective and acceptable to women, although the prevalence of side
effects was higher. Sublingual administration will
increase the choice available with regards to route of drug administration to
women undergoing medical abortion.
