Bhattacharjee 2008.
Methods | The patients were randomly allocated into two groups using a computer‐generated randomisation protocol. A computer‐generated randomisation sequence was used to assign participants into two treatment groups. The allocation was concealed in sealed, sequentially numbered, brown envelopes, which had been prepared by the statistician of each centre and handed over to the respective pharmacy department. | |
Participants | 277 pregnant women (group I: 139, group II: 138) Inclusion criteria: 13 ‐ 20 weeks singleton pregnancy, young healthy women. Exclusion criteria: gestation < 13 or > 20 weeks, contraindication for misoprostol use. |
|
Interventions | Group I: vaginal administration 400 μg misoprostol at the interval of three hours, up to a maximum
five doses over 24h. Group II: sublingual administration 400 μg misoprostol, at the interval of three hours, up to a maximum five doses over 24h. The patients were instructed to keep the tablets under the tongue until these were dissolved and not to spit out or swallow the content for at least one hour post‐administration. Those women, who failed to abort within 24 h of initiation of the treatment,received a second course of misoprostol, with the same allocated regimen, over a period of another 24 h. If a woman failed to abort after 48 h, the regimen was declared unsuccessful and she was offered a regimen of extra amniotic 0.1% ethacridine lactate infusion (single instillation) or repeated doses of dinoprostone gel (0.5 mg) in the cervical canal six‐hourly up to a maximum of three doses. |
|
Outcomes | Primary outcomes: induction to abortion interval, abortion within 24 and 48 hours. Secondary outcomes: blood loss, surgical evacuations, side‐effects. |
|
Notes | Definition of abortion: expulsion of fetus and placenta without operative intervention. Exploration of the uterus was performed under deep sedation or short general anaesthesia if the placenta was found to be incompletely expelled. No major complications reported. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ adequate |
Blinding? All outcomes | High risk | |
Free of other bias? | Low risk | No statistically significant differences between the groups in terms of maternal age, gestational age and parity. |