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. 2017 Aug 2;2017(8):CD001324. doi: 10.1002/14651858.CD001324.pub5

Van Santen 1985a

Methods Randomised, double‐blind trial. Random number sequence generated from a random number table. A numbered strip containing the capsules given to participating women. Masking achieved by giving each woman the active and corresponding placebo treatments. Side effects were assessed by women
Participants 465 healthy women attending Utrecht State University Hospital, the Netherlands
Included women with regular menstrual periods, who had had a single act of unprotected intercourse
Excluded women who were breastfeeding, on medications and difficult to follow up
Interventions Yuzpe (ethinyl oestradiol 100 μg + norgestrel 1 mg, repeated after 12 h) on day 1 + placebo capsules for 4 days vs ethinyl oestradiol 5 mg dose followed by a placebo capsule 12 h later followed by ethinyl oestradiol 5 mg single daily dose for 4 days
Outcomes Observed number of pregnancies, side effects and changes in menstrual pattern
Notes

  1. Observed pregnancy/expected pregnancy/total number of women: Yuzpe 1/11/200; ethinyl oestradiol 5 mg 2/12/184

  2. Loss to follow‐up 5.7% altogether
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "By using a table of random numbers, 465 women were given one of the two treatments."
Allocation concealment (selection bias) Unclear risk Allocation concealment method not explained
Blinding (performance bias and detection bias) All outcomes Low risk "Double blinded". "In the high‐dose estrogen treatment, the second capsule was inert, whereas in the EE + NG combination treatment, the capsules to be taken after the first day were placebo. In this fashion strips of wrapped capsules with a similar appearance were used throughout the study."
Incomplete outcome data (attrition bias) All outcomes Unclear risk Exact number of loss to follow‐up is not clear
Selective reporting (reporting bias) Low risk Planned outcome of pregnancy and side effects were reported and I am unclear on how they chose how many they analysed in each outcome
Other bias Low risk None detected