WHO 1980.
Methods | Location and time frame: Hungary, Belgium, Brazil, United Kingdom, Chile, and Germany Design: RCT at 6 centers Sample size calculation and outcome of focus: no mention |
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Participants | General with N: 841 healthy women Inclusion criteria: aged 16 to 40 years; having vaginal delivery; willing to rely on IUD for fertility regulation Exclusion criteria: recent history of pelvic inflammatory disease; sexually transmitted infection treated during current pregnancy; congenital abnormality of uterus or vagina; known or suspected genital tract malignancy; uterine fibroids; or evidence of infection during labor |
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Interventions | IUD inserted immediately after expulsion of placenta
Insertions were done with standard or modified IUD inserter or by manual placement at fundus. |
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Outcomes | Reported expulsion (partial or complete), pregnancy, removal for bleeding or pain, and other medical removal Assessment times: 6 and 12 months; follow‐up to 24 months |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization by computer‐generated table of numbers (from communication with investigators) |
Allocation concealment (selection bias) | Low risk | Sealed, opaque, sequentially numbered envelopes with method indicator card (from communication with investigators) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Trial was stopped prematurely because expulsion rates with all devices exceeded predetermined 20% limit. Women with expulsion within 48 hours after insertion were excluded from life‐table analysis (part of protocol). Loss to follow‐up (reported; time frame unclear): Postpartum T, 17.8%; Lippes Loop, 16.2%; Copper 7, 16% |