Comparing 200 μg and 400 μg sublingual misoprostol before surgical abortion; a Dutch single centre clinical pilot.
Stimezo Zwolle and ASK Mildredhuis Arnhem, Zwolle / Arnhem, The Netherlands
Study Question. To compare efficacy and side effects of 200 μg and 400 μg sublingual misoprostol for cervical priming prior to first trimester surgical abortion.
Summary Answer. This study indicates 200 µg misoprostol can be used for cervical priming prior to surgical abortion as the results showed fewer side effects but no difference in cervical dilatation in comparison to 400 µg misoprostol.
What Is Known Already. Administration of misoprostol prior to vacuum aspiration reduces complications and morbidity in first trimester pregnancies. As a result, the Dutch society of abortion physicians (NGVA) decided to adopt cervical priming with misoprostol in their standard operating procedure (SOP). However, the use of misoprostol is associated with various adverse effects such as abdominal pain, shivering and nausea. A study in the field of Prevention of Postpartum Hemorrhage have suggested that 200 µg misoprostol is just as effective as a 400 µg dose, but with a reduction of adverse effects. This could also be the case for cervical priming prior to surgical abortion.
Study Design, Size and Duration. This pilot was performed in a Dutch abortion clinic. In regard to the upcoming new SOP for first trimester abortions, all women attending this clinic were assigned to receive either 200 μg or 400 μg sublingual misoprostol prior to surgical abortion. The primary outcome was the complexity of the procedure (an efficacy parameter ), scored as dilatation on a scale of 1 to 5 and the secondary outcome was the presence of side effects before, during and after treatment. Pain registration was performed by the standardised VAS score. The pilot took place between October 2014 and June 2015.
Participants, Setting and Method. Women requesting a surgical abortion between 5 and 13 weeks of gestation were recruited for this pilot. Exclusion criteria were any contraindication for misoprostol or the administration of breastfeeding. Gestational age was established by ultrasound examination. The allocated dose of misoprostol (200 µg or 400 µg) was self-administered 1 hour prior to treatment. The women either received 1 tablet of 200 µg misoprostol or 2 tablets of 200 µg. Vacuum aspiration was performed under general or local anaesthesia according to clinical routine.
Main results. In total, 280 women were enrolled in this pilot. These women were divided into two groups; a group receiving 200 µg of misoprostol (n=144) and a group receiving 400 µg of misoprostol (n=136) for cervical priming. Cervical dilatation was measured based on a scale from 1 (manual dilatation was still needed) to 5 (no manual dilatation was needed). There was no difference found between both groups regarding cervical dilatation. This indicates that a difference of misoprostol dosage, when used for cervical priming, does not alter the complexity of the procedure. For the second objective of this study, the prevalence of adverse effects was measured by a questionnaire prior to treatment. A total of 145 side effects were measured in the 200 µg group and a total of 162 in the 400 µg group. 32% of the women who received 200 µg misoprostol experienced no side effects, while this percentage was lower in the 400 µg group (21%). There was a higher prevalence of shivering in the 400 µg group (14%) compared to the 200 µg group (9%) and a greater percentage of women in the 400 µg misoprostol group experienced nausea as a side effect (11,7%) in comparison to the women receiving 200 µg Misoprostol (4.8%). There was no difference in the prevalence of abdominal pain and the dryness of the mouth.