Kapp 2007.
Methods | Sequentially distributed study number in an allocation ratio of 1:1. The randomisation scheme used permuted blocks of eight, selected by a random number generator created using SAS V.9.3. The pharmacy dispensed the study medication. | |
Participants | 64 pregnant women (group I: 32, group II: 32) Inclusion criteria: 18‐23 weeks of gestation. Exclusion criteria: known allergy to mifepristone/misoprostol/prostaglandins, preexisting intrauterine fetal demise, premature preterm rupture of membranes, IUD in place, history of chronic adrenal failure, porphyrias, concurrent long term corticosteroid treatment. |
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Interventions | All: intra‐amniotic injection of 1.5 mg digoxin, then: Group I: 200 mg mifepristone, 20–24 hours after study capsule: misoprostol induction using 400 μg misoprostol, followed by 200 μg every 6h (buccally); Group II: 2 placebo tablets (vitamin C). 20–24 hours after study capsule: misoprostol induction using 400 μg misoprostol, followed by 200 μg every 6h (buccally). |
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Outcomes | Primary outcome: median interval from first misoprostol dose to fetal expulsion. Secondary outcomes: women delivering within 24 hours, proportion of women with a complete delivery requiring additional treatment for retained placenta, the amount of required pain medication, length of hospital stay, side‐effects. |
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Notes | Definition of abortion: expulsion of fetus. If the placenta was incomplete or failed to be expelled after 4h, an evacuation of the uterus was carried out under general anaesthesia. Heavy bleeding occurred in two women. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ adequate |
Blinding? All outcomes | Low risk | Blinding for participants, clinicians, and researchers. |
Free of other bias? | Low risk | No statistically significant differences between the groups in terms of maternal age, gestational age and parity. |