Lester 2015.

Methods	Location and time frame: Kampala, Uganda, from February 2011 to December 2011 Design: RCT; pilot study to determine feasibility of study Sample size calculation and outcome of focus: based on literature and postpartum return rates at Mulago, 40% do not return for delayed insertion and 10% discontinue in 6 months. 90% immediate group and 54% delayed group would use IUD at 6 months. Sample 30 per group for 84% power (β = 0.16) to detect difference of 36% between groups, using significance level 0.05
Participants	General with N: 68 randomized in national referral hospital Inclusion criteria: pregnant at enrollment; scheduled for cesarean delivery > 8 hours after consent; desires copper IUD; age ≥ 18; English or Luganda speaking; willing to be accompanied home from hospital and to have address recorded; willing to have home visit at 6 months postpartum if no return for scheduled visit Exclusion criteria: allergy to copper; pelvic tuberculosis; severe thrombocytopenia; positive test for gonorrhea or Chlamydia; leiomyomata or other anomaly that prevents IUD placement; cervical cancer or carcinoma in situ; desire for repeat pregnancy < 12 months; chorioamnionitis; preterm birth < 34 weeks; diagnosis of AIDS (HIV not exclusion criterion); fetal demise; hemorrhage; ruptured uterus; eclampsia; evidence of severe anemia Post‐enrollment exclusion criteria: participant no longer desires CuT 380A or for immediate insertion, interval development of any exclusion criteria; postpartum hemorrhage with active bleeding that does not allow IUD placement in 10 minutes of placenta delivery; prolonged rupture of membranes > 12 hours for standard insertion, diagnosis of active cervical infection in 3 months of planned insertion or active pelvic or cervical infection; pus at cervical os or any concern for upper genital tract infection, including fever or uterine or adnexal tenderness; diagnosis of new pregnancy; interval development of any exclusion criteria
Interventions	CuT 380A IUD inserted after cesarean section Treatment: immediate postplacental (within 10 minutes) Comparison: standard (6 weeks)
Outcomes	IUD insertion and use at 6 months post delivery, time to IUD expulsion, time to pregnancy; safety measures (infection, uterine perforation), vaginal bleeding, satisfaction Assessment times: delivery, 6‐week postpartum visit, phone at 3 months, clinic visit at 6 months
Notes	Information obtained from full report as well as ClinicalTrials.gov. Results from related abstract are also mentioned (see Averbach 2012).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Permuted‐block randomization scheme with block sizes of 4 and 6
Allocation concealment (selection bias)	Low risk	Sequentially numbered, opaque envelopes; opened after delivery of baby and placenta, given no intraoperative exclusion criteria developed
Blinding of participants and personnel (performance bias) All outcomes	High risk	None used
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up: 10% (7/68); immediate 15% (5/34) and delayed 6% (2/34)