Oral versus self-administered vaginal misoprostol at home before surgical termination of pregnancy: a randomised controlled trial

Abstract

Objective: To compare the impact of 400 mug oral versus self-administered vaginal misoprostol at home on pre-operative cervical priming in both primigravid and multigravid women prior to first trimester surgical abortion.

Design: Randomised controlled trial.

Setting: Norwegian University Teaching Hospital.

Sample: Three hundred and thirty-eight women undergoing surgical abortion between 7 and 12 weeks of gestation.

Methods: The women were randomised to either 400 microg of oral misoprostol the evening before or 400-microg of self-administered vaginal misoprostol at home the same day as vacuum aspiration. Main outcome measures Pre-operative cervical dilatation, complications and acceptability.

Results: The median cervical dilatation was 6.2 mm (range 0-11 mm) for the women in the 400 mug oral misoprostol and 6.5 mm (range 0-11 mm) in the 400-microg vaginal misoprostol groups. The median pre-operative dilatation was larger in multigravidae (6.4 and 6.7 mm for the oral and vaginal routes, respectively) than in primigravidae (5.8 and 6.0 mm, respectively). In primigravidae, 19% achieved a pre-operative dilatation of > or = 7 mm, with no significant difference between oral and vaginal dosage. In multigravidae, 52% achieved a pre-operative dilatation of > or = 7 mm with vaginal dosage, compared with 36% with oral dosage (P = 0.03). There was no difference between non-immigrant versus immigrant women in pre-operative cervical dilatation. The 400-microg oral dosage group had a higher risk of bleeding, compared with the group receiving 400-microg vaginal misoprostol [odds ratio (OR) = 10.4; confidence interval (CI) 5.2-20.8]. There was no difference between non-immigrant and immigrant women in acceptability of self-administered vaginal misoprostol; almost all women found this administration route acceptable. Complications were minor and were distributed equally between the two dosage groups.

Conclusions: The vaginal route will result in a satisfactory dilatation in about half of multigravidae but is much less effective in primigravidae. The oral route does not lead to satisfactory dilatation in either group and is associated with a higher occurrence of pre-operative bleeding. Self-administered vaginal misoprostol at home is highly acceptable.