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 |