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. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3

Espey 2014.

Methods Location: Albuquerque, NM, USA
Recruitment time: January 2010 to January 2013
Sample size calculation and outcome of focus: Assuming two‐sided alpha of .05 and a power of 80%, sample size of 80 women needed to detect 0.8 cm ± 1.25 difference in maximum pain with IUD insertion.
Participants General with N: 83 nulliparous women
Source: university reproductive health clinic
Inclusion criteria: nulliparous women, desiring LNG‐IUS or CuT 380A IUD for contraception, English‐speaking, age ≥ 18 or age 14 to 17 with parental consent
Exclusion criteria: history of pregnancy lasting beyond 19 6/7 weeks, any pregnancy in last 4 weeks, active genital infection or cervicitis, undiagnosed abnormal uterine bleeding, fibroids distorting uterine cavity, history of cervical or uterine cancer, uterine anomaly, PID within last 3 months, and ibuprofen or copper allergy
Interventions 1) Misoprostol 400 μg, buccally
2) Placebo
Timing: 2 to 8 h before the IUD insertion
Outcomes Primary: pain related to IUD insertion, assessed immediately after insertion (instruments removed) and pain before clinic discharge (10 cm VAS with 0 = none and 10 = worst imaginable pain)
Secondary: satisfaction and side effects (1 to 2 weeks later)
Notes IUC used: LNG‐IUS or CuT 380A
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated, 8‐block randomization sequence
Allocation concealment (selection bias) Low risk Pharmacy prepared medication at another university.
Drug and placebo tablets packaged according to randomization list, labeled with consecutive numbers, and pulled in sequential order
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants and investigators were blinded to assignment to treatment groups.
Drug and placebo tablets were identical in appearance, taste and smell, and packaging.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Loss to follow‐up: none for pain related to IUD insertion; also had follow‐up at 1 to 2 weeks