Cremer 2011.
| Methods | Open labelled randomised controlled trial. Randomisation was done using computer generated table of random numbers | |
| Participants | 215 women, 16 years or older. Inclusion criteria: intrauterine pregnancy > 14 weeks gestation, desires abortion, desires IUD for contraception, no contraindication for dilation and evacuation abortion Exclusion criteria: uterine anomaly including fibroids if they distort the uterine cavity, acute PID, uterine or cervical neoplasia or unresolved abnormal PAP smear, untreated acute cervicitis or vaginitis, chlamydia or gonorrhoea infection in past 90 days, acute liver disease or liver tumour, woman or partner currently with multiple sexual partners, history of Wilson's disease, hypersensitivity to any component of Copper T IUD |
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| Interventions | Copper T 380A IUD: Immediate insertion ‐ IUD inserted within 15 minutes after delivery of the placenta immediately following abortion Delayed insertion ‐ IUD inserted at the post‐operative visit 2 to 4 weeks after the abortion | |
| Outcomes | Primary: use at 6 months Secondary: satisfaction, expulsion by 6 months, use of other contraceptives, infection and repeat abortion | |
| Notes | This study was previously listed under ongoing studies | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was done using computer generated table of random numbers |
| Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque sealed envelopes were opened on the day of abortion. Randomisation was not known until final day of procedure if abortion was a two‐day procedure |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | assessment was done by participants and not by providers |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not all randomised participants were included in the final analysis. Participants lost to follow‐up were not included in the analysis of important outcomes |
| Selective reporting (reporting bias) | Unclear risk | Unclear |
| Other bias | Unclear risk | Not all randomised participants were included in the final analysis |