Scavuzzi 2013.
Methods | Location: Recife, Pernambuco, Brazil Recruitment time: January 2009 to November 2011 Sample size calculation and outcome of focus: Considering frequency of subjective difficulty in inserting IUD of 45% in placebo and 50% reduction in rate with use of misoprostol, adding 20% for dropout: 190 calculated using OpenEpi software program. |
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Participants | General with N: 190 nulligravid women Source: family planning clinic of Institute of Medicine in Recife Inclusion criteria: nulligravidas, reproductive age, never had surgery of uterine cervix and requested IUD as contraceptive method Exclusion criteria: contraindication to IUD use as defined in categories 3 and 4 of medical eligibility criteria for contraceptive use (WHO 2004) |
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Interventions | 1) Misoprostol 400 μg, vaginally 2) Placebo Timing: 4 h prior to IUD insertion |
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Outcomes | Primary: pain at insertion (0 to 10 scale, 0 = absence of pain and 10 = worst pain imaginable); categorized as 'absent or mild' (0 to 5) and 'moderate or severe' (6 to 10) Secondary: side effects (prior to (used in this review), during, and 24 h after IUD insertion) and satisfaction |
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Notes | IUC used: CuT 380A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization carried out (1:1) using block randomization method by Random Allocation Software program, version 1.0 (Isfahan, Iran), and labeled using letters A and B. List sent to pharmaceutical company, where coding (misoprostol or placebo) of each letter A and B, was randomly selected. |
Allocation concealment (selection bias) | Low risk | Each woman was identified by sequential ordinal number corresponding to sealed box containing medication or placebo. Each box was identified with woman’s name and registration number, and only opened when tablets had to be inserted into vagina. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Neither investigator nor woman was aware if misoprostol or placebo was to be administered. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: 1 woman in misoprostol group discontinued study after having medication |