The I’M WOMAN Trial assess the benefits of intramuscular TXA in Tanzania
The I’M WOMAN Trial team at LSHTM visited Tanzania in October 2024. The trial is collaborating with the University of Dar es Salaam, Tanzania’s National Coordinating Centre for the trial, alongside six regional referral hospitals, two regional hospitals and one national hospital.
Dr Amy Brenner, Principal Investigator of the I’M WOMAN Trial at LSHTM, said:
“The collaborators meeting was a great opportunity to build stronger connections with the trial team based in Tanzania. We shared trial experiences and best practices to date, discussed obstacles and put plans in place to streamline trial procedures. We hope this will enhance recruitment and ensure data quality.”
The I’M WOMAN Trial team is looking at whether giving tranexamic acid (TXA) before childbirth, and into a muscle, rather than a vein, can reduce postpartum bleeding and improve outcomes for women. The trial is also recruiting women in Pakistan and Nigeria where many women bleed to death after childbirth. By finding easier ways to give TXA, the trial hopes that women everywhere will have access to this lifesaving drug, if they need it.
During the trip, the team saw first-hand the speed of an intramuscular (IM) injection, compared to TXA administered intravenously (IV).
The video below shows how, in busy healthcare settings, injecting TXA into a muscle is much more convenient for healthcare workers and as it is quicker and simpler to administer, which could greatly expand access to this important medicine.
Please note: the following video contains a needle injection.
Currently, the World Health Organization guidelines advise that women with PPH receive TXA as soon as possible, and within three hours after giving birth, regardless of the cause of PPH or mode of birth.
Tranexamic acid is more effective when given early, around the time bleeding starts. Every 15 minutes delay reduces the survival benefit by about 10%.
The WOMAN-2 Trial has shown that giving IV TXA after cord clamping does not prevent a clinical diagnosis of PPH in anaemic women. Anaemia is a strong risk factor for PPH —the more severe the anaemia, the higher the risk of PPH and the sooner after birth the diagnosis is made. Giving TXA earlier, before birth, could be successful in reducing bleeding after childbirth. Giving TXA before the bleeding becomes serious should, therefore, maximise the benefits.
Dr Alfred Charles Secha, Medical Officer in obstetrics and gynaecology at Muhimbili National Hospital, Tanzania, and Research Fellow in the I’M WOMAN and WOMAN-2 Trials said:
“Tranexamic acid should be given early and [..] when you have a condition where you cannot access the intravenous line and you want to help women not to bleed much, the IM site will be easier for the woman who cannot access the intravenous line.”
On the benefits for women giving birth at lower-level health facilities, for example, outside of regional referral hospitals, he said:
“In the national hospital or other regional referral hospitals we have the advantage of getting expertise like the anaesthesia team […] but facilities at the lower-level cannot access such expertise, so giving them the assurance that intramuscular can work as best as intravenous will be easier for them (women).”
In many countries where maternal deaths are prevalent, clinicians and other healthcare workers are either not aware of TXA as a form of treatment for PPH, do not feel confident in using it, do not have access to TXA due to inadequate procurement or price injustice, or are not trained to administer it intravenously.
The I’M WOMAN Trial aims to raise awareness of TXA in Tanzania, Nigeria, Pakistan and Ethiopia. The trial works closely with clinicians to ensure they are comfortable using TXA and that women with severe bleeding after childbirth can benefit from access to TXA. Ultimately, we hope to reduce global maternal deaths as PPH remains the leading cause of maternal mortalities worldwide.
