Cameron 2013.
Methods | Location: Scotland, UK Recruitment time: from March 2009 to March 2011 Sample size calculation and the outcome of focus: Assuming two‐sided alpha of 0.05 and power of 80%, a sample size of 100 participants in each arm was calculated to detect difference between 90% easy insertions with empty bladder and 99% easy insertions with filled bladder. |
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Participants | General with N: 200 women Source: family planning clinic in Edinburgh, Scotland, UK Inclusion criteria: wished to have an intrauterine method of contraception, routinely attended clinic for counseling about method by clinician, before being given an appointment for subsequent insertion of device, agreed to attend for IUD or IUS insertion with full bladder Exclusion criteria: no other criteria |
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Interventions | Women drank 1 liter (L) (or 6 glasses) of fluid in hour before appointment.
Timing of bladder emptying: 1) Immediate: went to toilet immediately prior to IUC insertion 2) Delayed: went to toilet after IUC insertion |
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Outcomes | Primary: pain during IUD insertion (10‐point scale where 0 = no pain and 10 = agony) Secondary: ease of insertion (primary for trial) |
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Notes | IUC used: Mirena, Slimline TT380, Nova T 380, Multiload 375, UT 380 and Mini TT 380 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence in blocks of 10 |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque, sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: none |