Procedure for unblinding if needed {17b}
PPH, voice
ADVERSE REACTION
There should be no need to unblind the allocated treatment. If a woman develops PPH, she should receive all clinically indicated treatments, which can include tranexamic acid. Because a second 1-g dose of tranexamic acid is well within the usual dosing range, it is not necessary to find out whether a particular woman received tranexamic acid or placebo as part of the I’M WOMAN trial. Even if a particular woman has received tranexamic acid within the trial, a second 1-g dose of tranexamic acid can safely be given. Nevertheless, if the clinician believes that a woman’s care depends importantly upon knowledge of whether the participant received tranexamic acid or placebo, it is possible to unblind. If urgent unblinding is necessary, the CTU will provide an emergency 24-h telephone service. The caller will receive a voice message, text message or email informing them whether the woman received tranexamic acid or placebo. The investigator should complete an unblinding request/report form within five working days of unblinding. If a suspected unexpected serious adverse reaction (SUSAR) is reported, unblinding may be needed for reporting to regulatory agencies and ethics committees.