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. 2015 Jun 26;2015(6):CD003036. doi: 10.1002/14651858.CD003036.pub3

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
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
Interventions Insertion of CuT 380A within 10 minutes after placenta delivery
Treatment: insertion by hand
Comparison: insertion with ring forceps
Outcomes Pregnancy, expulsion, and continuation rates
Assessment times: 3 and 6 months
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%