As 2023 draws to a close, we reflect on what a year it has been for the WOMAN Trials. Below some of the team give their thoughts on what have been 12 months full of challenges and successes, as well as looking ahead to 2024 when the trial results for the WOMAN-2 Trial – seven years of work – will finally be announced.
Alice Kawala, Assistant Trials Coordinator, Tanzania
“In the heart of Tanzania, I would like to thank LSHTM’s Clinical Trials Unit, as it shines as a beacon of change, leading a transformative trial project. Your unwavering commitment and innovative approaches redefine possibilities, instilling pride and illuminating a brighter, healthier path for women in Tanzania.”
Amber Geer, Clinical Trials Data Manager:
“It’s so exciting that we will soon be finding out the results of the trial having worked on it since day one! I’m especially impressed by how hard our collaborators have worked in these last few months to get the data ready for analysis, everyone has been working so hard to make sure our data is of the highest quality.”
Amy Brenner, Assistant Professor and Principal Investigator of I’M WOMAN Trial:
“This year, I have been most proud to be part of such a fantastic team based all over the world. Having so many dedicated colleagues that form the WOMAN Trials Collaboration keeps me motivated, especially when things get tough – there is no end to obstacles in clinical trials!
“Next year, I am very excited for the WOMAN -2 Trial results and look forward to I’M WOMAN recruitment and continued progress towards improving maternal health worldwide.”
Dr Baya Kissiwa, Principal investigator, Amana site, Tanzania:
“We are very excited and proud to be part of the WOMAN-2 Trial team and hope our participation will contribute to changes in the world of science.
“The WOMAN-2 Trial has helped us to increase our knowledge of managing pregnant women with anaemia during labour and delivery as no randomised trial has ever been done before in our hospital involving such participants despite the higher prevalence of anaemia that we have.”
Collette Barrow, Trial Administrator:
“I was asked to help with the voiceover for the anaemia video created by Formed Films. It was the first time I’d done anything vocal and found the experience to be exciting and fulfilling.”
Eni Balogun, Research Fellow – Senior Trial Manager:
“It has been amazing to witness the renewed focus on tackling severe bleeding after childbirth (PPH) which claims the lives of around 70,000 women each year. A key part of this was PPH stakeholders coming together to agree a roadmap of activities to address this preventable and treatable condition. One area identified for priority research is whether tranexamic acid can prevent PPH in anaemic women and we are really excited that the WOMAN-2 Trial results will soon be available in 2024 to answer this important question!”
Professor Haleema Shakur-Still, co-lead of the WOMAN-2 Trial:
“As 2023 ends, and I look forward to the results of the WOMAN-2 Trial and the potential lives which we hope could be saved, I reflect on the difficulties faced by all, but especially women, as they strive to live and survive in war zones, as refugees and in poverty.
“According to the UNHCR, women and girls make up 50% of refugee, displaced and stateless persons, of which half are young women and 4% are pregnant. The UN has identified that there are more than 50,000 pregnant women and an average of 180 births a day in Gaza. Women deserve quality healthcare and the right to give birth in a safe place.”
Professor Ian Roberts, co-lead of the WOMAN-2 Trial:
“Reaching 15,000 in the WOMAN-2 Trial was obviously a highlight. You would not believe how many obstacles were overcome to get there. A fantastic team achievement.
“Hearing Professor Rizwana (National Trial Coordinator in Pakistan) present the data on anaemia and the risk of postpartum haemorrhage (PPH) at the Global Summit on PPH in Dubai. A strong woman with strong data – unstoppable! The data had a huge impact. Many obstetricians did not know that anaemia increased the risk of PPH.
“Seeing new evidence that anaemia increases the risk of PPH including PPH ‘due to’ uterine atony was special. It reminded me of the quote by Huxley: ‘The great tragedy of Science is the slaying of a beautiful hypothesis by an ugly fact.’
“We know less than we think about PPH!”
Julio Gil Onandia, Clinical Trials Assistant:
“The WOMAN-2 Trial saw an incredible 99.98% completion rate for outcome forms across all participating sites – a truly impressive achievement. Being able to contribute to this success fills me with immense pride and satisfaction. Let’s hope this has a positive impact on the trial results!”
Llion Roberts, Assistant Trial Manager:
“Working on such a worthwhile project has been an absolute pleasure. Seeing teams from all over the world pulling together to answer this important question has been inspirational. Fingers crossed for a clear answer on whether TXA reduces the incidence of PPH.”
Monica Arribas, Senior Trial Manager:
“The I’M WOMAN trial is getting ready to start recruitment early next year. All collaborators are hugely motivated to improve the care of women at risk of postpartum haemorrhage. If the intramuscular route of TXA administration works as well as the as the intravenous route in reducing postpartum bleeding, many more women around the world could benefit from this life-saving treatment.”
Olujide Okunade, Trials Coordinator, Nigeria:
“Someone once said that:
‘You are remembered for one of two things – the problems you created or the ones you solved.’
“To those sites where we eventually were able to conduct the WOMAN-2 Trial in Nigeria, we’ll always remember you for the problems you helped to solve.”
Danielle Prowse, Data Manager:
“It’s been a long but incredible journey working on the WOMAN-2 trial since it’s very inception. We have worked hard to ensure we are collecting the outcomes that matter the most to patients and that the data is of the highest quality. I am so excited to see the answers this large dataset will be able to provide, and the changes it will cause for obstetrics worldwide. We can never thank our collaborators and the patients who agreed to take part in the trial enough, to whom the trial would not be possible without”
Professor Rizwana Chaudhary, Assistant Professor Aasia Kayani and Assistant Professor Kiran Javaid from the Pakistan Trials team:
“The end of 2023 marks the completion of WOMAN-2 recruitment, a monumental achievement in itself. In accomplishing it, we went through a terrain fraught with challenges. Regulatory hurdles stood as formidable peaks, demanding strategic ascents. Navigating through both predictable and unforeseeable obstacles is the hallmark of this expedition. Each participant becomes a cherished companion in this journey. The thrill isn’t just in overcoming hurdles but in the anticipation of revelations that may redefine the future of healthcare.”
Rose Temba, Assistant Trials Coordinator, Tanzania:
“My hope, as we unveil the results of the WOMAN-2 Trial next year, is that in every data point and statistic there will be hope, resilience, and the relentless pursuit of progress in women’s health.”
Dr Sima Berendes, Research Fellow
“I have been excited to join the WOMAN Trials team this year and continue to be amazed by its wonderful work. I very much look forward to our new endeavours next year (WOMAN-3 !).”