Xu 1996.
Methods | Location and time frame: Shanghai, China, from October 1993 to October 1994 Design: RCT at 13 centers Sample size calculation and outcome of focus: 439 per group (hand versus instrument insertion) for study power of (alpha = 0.05, 1 ‐ beta = 0.9, and f = 0.10); 500 planned to account for attrition; expulsion was outcome of interest |
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Participants | General with N: 910 healthy women in antenatal care Inclusion criteria: age 20 to 40 years; no contraindications for IUD use; willing to rely solely on the IUD for fertility regulation; normal vaginal delivery (no complications during labor and delivery) Exclusion criteria: no mention |
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Interventions | Insertion of CuT 380A within 10 minutes after placenta delivery Treatment: insertion by hand Comparison: insertion with ring forceps |
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Outcomes | Pregnancy, expulsion, and continuation rates Assessment times: 3 and 6 months |
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Notes | Investigator provided women‐months for rates. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number sequence (from correspondence with investigator) |
Allocation concealment (selection bias) | Low risk | Sealed, sequentially numbered opaque envelopes (from correspondence with investigator) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both participants and evaluators were blinded from knowing the insertion method. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up (reported 6‐month): hand insertion 3% and instrument insertion 7% |