The results were released in the British Journal of Obstetrics and Gynaecology.
Serious bleeding after childbirth, or postpartum hemorrhage (PPH), is among the leading causes of maternal death worldwide, with most of the 70,000 yearly deaths taking place in low-and middle-income nations (LMICs).
Results from the earlier WOMAN trial, led by scientists from LSHTM with cooperation from 21 countries, provided vital evidence for the life-saving potential of repurposing TXA for dealing with PPH.
Originally utilized in surgery and later in injury, TXA works by inhibiting the breakdown of blood clots.
Although intravenous administration of TXA is the very first port-of-call for treatment, lots of births in LMICs happen in the house, with access to health care settings often restricted. Consequently, the focus has shifted towards finding alternative administration routes.
In this trial, a worldwide research group, including from LSHTM, recruited over 120 ladies aged 18 or older who were due to deliver by cesarean area at 2 hospitals in Pakistan and one in Zambia in between December 2020 and June 2021. All females had several threat elements for postpartum hemorrhage.
The research study is the first trial screening several different routes of administration in females delivering and especially the very first to check the intramuscular route, particularly in pregnant women.
In general, intramuscular and oral TXA were well tolerated, without any major side results for moms or babies. Target concentrations of TXA in maternal blood were attained for both routes, although for oral TXA this took an hour– a particular that might prevent its use in emergency treatment. Intramuscular TXA, however, reached therapeutic concentrations within 10 minutes of injection, which was maintained for over 4 hours.
The authors conclude that these findings supply enough evidence to conduct comparative Phase 3 scientific trials (IM WOMAN) beginning in August this year. These will intend to figure out if intramuscular administration is as reliable as intravenous routes in minimizing postpartum bleeding.
Professor Haleema Shakur-Still, co-author and Professor of Global Health Clinical Trials at LSHTM said: “In numerous LMICs, females do not deliver in health care centers, so if TXA can be offered just as successfully intramuscularly as through intravenous injection, this could be of substantial significance to the countless ladies who pass away every year from PPH.”
Professor Rizwana Chaudhri, co-author based at Shifa Tameer-e-Millat University, Islamabad, Pakistan said: “The intramuscular route will be very valuable in Pakistan. With some patients who are experiencing a PPH, it is hard to get an intravenous line developed, so anything that can minimize PPH will be useful. In some cases, it will be the first and last option.”
Dr Mwansa Ketty Lubeya, co-author based at The University of Zambia-School of Medicine, Women and Newborn Hospital-UTH stated: “In Zambia, we are still having a hard time with access to TXA. There is no point in having TXA when canulation is not an option.
Dr Ian Roberts, co-author and Professor of Epidemiology at LSHTM stated: “We have excellent factor to believe the intramuscular path will be as efficient as the intravenous path to lower postpartum bleeding. In August, we are starting a large global trial to show this in the hope that this will alter WHO guidelines. We wish to make this lifesaving treatment offered to all ladies anywhere they deliver.”
Recommendation: “Alternative paths for tranexamic acid treatment in obstetric bleeding (WOMAN-PharmacoTXA trial): a randomised trial and pharmacological research study in caesarean area births” by Haleema Shakur-Still, Ian Roberts, Stanislas Grassin-Delyle, Rizwana Chaudhri, Amber Geer, Monica Arribas, Elodie Lamy, Raoul Mansukhani, Mwansa Ketty Lubeya, Kiran Javaid, Aasia Kayani, Naila Israr, Syeda Batool Mazhar, Saïk Urien, Naïm Bouazza, Frantz Foissac, Danielle Prowse, Laura Carrington, Collette Barrow, Julio Gil Onandia and Eni Balogun, 5 April 2023, British Journal of Obstetrics and Gynaecology.DOI: 10.1111/ 1471-0528.17455.
The study was moneyed by the Bill and Melinda Gates Foundation and the Wellcome Trust.
Overall, intramuscular and oral TXA were well tolerated, with no serious side results for newborns or moms. Target concentrations of TXA in maternal blood were attained for both paths, although for oral TXA this took an hour– a characteristic that could prevent its usage in emergency treatment. Intramuscular TXA, however, reached restorative concentrations within 10 minutes of injection, which was maintained for over 4 hours.
Dr Mwansa Ketty Lubeya, co-author based at The University of Zambia-School of Medicine, Women and Newborn Hospital-UTH stated: “In Zambia, we are still having a hard time with access to TXA. There is no point in having TXA when canulation is not a choice.
A current research study revealed that tranexamic acid (TXA), a drug utilized for severe post-childbirth bleeding, is safe and reaches therapeutic levels without delay when administered intramuscularly, and likewise is well-tolerated in oral form, though it takes longer to reach therapeutic blood concentrations. By providing TXA through several paths, consisting of oral and intramuscular administration, this life-saving treatment can potentially become more accessible to all women internationally, especially in low and middle-income countries where health care facilities may be less readily available or births often take place in the house.
A research study, involving the London School of Hygiene & & Tropical Medicine (LSHTM) researchers, has revealed that tranexamic acid (TXA), a drug targeted at tackling serious postpartum bleeding, can be securely administered intramuscularly to pregnant women, quickly attaining effective healing levels.
These outcomes, stemmed from the Woman-PharmacoTXA Phase 2 trial, highlight the capacity of utilizing intramuscular injection as an alternative to the prevalent intravenous methods. The latter often shows not practical in situations such as home births or in remote healthcare environments.
Oral TXA was likewise well-tolerated, however, on average, took around one hour to reach healing blood concentrations, meaning it could be unsuitable for first aid.