| Methods |
Randomised controlled trial without blinding. Randomisation by computer‐generated random number table. One participant who had a problem within 48 hr of insertion was excluded from analysis |
| Participants |
1060 women at 6 hospitals (in Egypt, United Kingdom, Zambia, Philippines, Chile, and Singapore) who were admitted for care of spontaneous abortions. Nearly all had sharp curettage for completion; suction curettage was rare. From 18% to 25% of the participants were 13‐20 weeks pregnant at the time of spontaneous abortion |
| Interventions |
Randomly assigned to one of three different IUDs: T Cu 220C, Lippes Loop D, or Copper 7 (all immediate insertion). Prophylactic antibiotics were not used |
| Outcomes |
Pregnancy (none of which was ectopic), uterine perforation, expulsion, and total medical removals (further broken down as pelvic inflammatory disease, pain alone, bleeding alone, pain/bleeding, and other) |
| Notes |
The report provides no a priori hypothesis or sample size and power calculation. Given the high proportion of abortions after 12 weeks and that legal abortion is unavailable or inaccessible in several of these countries, many of these "spontaneous" abortions were likely induced, possibly by unsafe methods. Thus, the risk of infection may be increased in this population. Non‐medical and other reasons for discontinuation (such a desire for pregnancy) are not included in this review. No subjects who had an expulsion or removal of the device were readmitted to the study, thus analysis was based on first‐segment event rates. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation by computer‐generated random number table |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelopes; commuictions with authors confirmed that envelopes were opaque and sequentially‐numbered. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No blinding |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
No blinding |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
No blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Unclear |
| Selective reporting (reporting bias) |
Low risk |
Not detected |
| Other bias |
Unclear risk |
Unclear |
