Background
Postpartum haemorrhage (PPH) causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. Intravenous (IV) TXA reduces deaths due to PPH by one third when given within 3 hours of childbirth. The WHO recommends that all women having a PPH get TXA as soon as possible, alongside all other treatments.
Because TXA is more effective when given early and PPH usually occurs soon after childbirth, giving TXA just before childbirth might prevent PPH from happening in the first place. Several clinical trials have examined TXA for the prevention of PPH, but the results are inconclusive.
The I’M WOMAN trial will evaluate the effects of TXA for PPH prevention in women with one or more risk factors for PPH giving birth vaginally or by caesarean section. The trial will also evaluate the effect of the route of TXA administration.
TXA is usually given by slow IV injection but recent research shows that TXA is well tolerated and rapidly absorbed after intramuscular (IM) injection, achieving therapeutic blood levels within minutes of injection.There may be fewer side effects with IM TXA because peak blood concentrations are lower than with the IV route. IM TXA also has practical advantages as it is quicker and simpler to administer.
trial Overview
Aim: To assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid (TXA) in women at increased risk of postpartum haemorrhage (PPH)
Objectives:
1. Assess the effect of TXA on the risk of PPH and other bleeding-related outcomes;
2. Compare the effects of IM and IV TXA on the risk of PPH;
3. Compare the effects of IM and IV TXA on the risk of adverse events.
Trial Design: A randomised, placebo-controlled, three arm trial
Population: About 30,000 women thought to be 18 years or older, having a vaginal or caesarean birth, who are at increased risk (one or more risk factors) of PPH
Exclusion criteria: Women who have a clear indication or contraindication for TXA
Setting: Hospitals in Africa and Asia (Pakistan)
Trial treatment:
a) 1 gram of tranexamic acid as two 5 ml IM injections (100 mg/ml) and IV placebo (10 ml 0.9% sodium chloride);
b) 1 gram of tranexamic acid by IV injection and two 5 ml IM placebo injections; or
c) matching placebo.
The trial treatment will be given just prior to skin incision (after draping) in caesarean births and at crowning in vaginal births.
Primary outcome: A clinical diagnosis of PPH
