Chen 2010.

Methods	Location and time frame: Pittsburgh, PA (USA), from May 2007 to October 2008 Design: randomized controlled trial Sample size calculation and outcome of focus: expected 40% of standard insertion participants would not return for insertion, 4% of inserted IUDs would be discontinued in 6 months because of removal requests, and expulsion would be 11% immediate group and 2% standard group; estimated proportions continuing IUD at 6 months were 0.850 immediate and 0.564 standard; 92 participants (46 per group) for 80% power to detect 34% difference in use at 6 months and significance level 0.05. Increased to 51 per group to allow 10% loss to follow‐up. Expected 40% would not be eligible for insertion because of post‐enrollment ineligibility criteria, increasing the total to 168.
Participants	General with N: 124 randomized; 102 remained eligible after randomization Inclusion criteria: 18 years and older; ≥ 24 0/7 weeks pregnant at enrollment; anticipates vaginal delivery; desires LNG system for postpartum contraception Exclusion criteria: scheduled cesarean section; allergy to polyethylene or levonorgestrel or other contraindication to LNG‐IUD use; exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy without subsequent negative test of cure; leiomyomata > 3 cm diameter; uterine anomaly (other than repaired septate uterus); current cervical cancer or carcinoma in situ; desires repeat pregnancy within 1 year of delivery Post‐enrollment ineligibility: cesarean delivery; clinical diagnosis of chorioamnionitis; sexually transmitted infection without negative test of cure; rupture of membranes for > 24 hours; postpartum hemorrhage; rupture of membranes at < 34 weeks gestation; participant no longer desires IUD; precipitous delivery so investigators could not begin within 10 minutes; investigators not notified of labor and delivery
Interventions	LNG‐IUS insertion Treatment: immediate (within 10 minutes postplacental) Comparison: standard (6 to 8 weeks postpartum)
Outcomes	Insertion, IUD use, continuation of IUD, expulsion, pregnancy (tested), safety (infection and perforation), pain with insertion, quality of life, contraceptive use Assessment times: visit 6 to 8 weeks post delivery, phone interview at 3 months, and visit at 6 months
Notes	Among women randomized to immediate insertion, 5 had IUD inserted from 11 to 15 minutes postplacental.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random allocation
Allocation concealment (selection bias)	Low risk	Opaque sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Study staff performing 3‐ and 6‐month evaluations were blinded to randomization assignment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up: 12% (5 immediate and 7 standard) Ineligible after randomized as per study criteria: 18% each group