Improving women’s health: stories from the I’M WOMAN Trial team
On 11 February, International Day of Women and Girls in Science, we celebrate the trial team’s dedicated research in Nigeria, Pakistan, Tanzania and Ethiopia in reducing global maternal deaths. The I’M WOMAN Trial is led by a multidisciplinary and international team of leading scientific experts, many of whom are women. Their expertise includes data science, epidemiology, health economics and clinical practice in obstetrics and gynaecology.
The I’M WOMAN Trial team is examining the effects of treating severe postpartum bleeding with tranexamic acid intramuscularly, rather than intravenously, to treat women with postpartum haemorrhage (PPH) faster. Hear from women in the I’M WOMAN Trial team below to find out what it’s like to work on this clinical trial, from visiting hospitals in our collaborating countries to collecting data from women who participated in the trial.
What is your role in the I’M WOMAN Trial?
Aasia Kayani, Assistant Professor, Pakistan National Coordinating Centre
As a trained medical doctor and obstetrician, I coordinate the I’M WOMAN Trial in various hospitals in Pakistan.
Monica Arribas, Senior Trial Manager
I ensure that recruitment is on track, the data is of the best quality and the trial adheres to regulatory and ethical guidelines that protect patient safety. Most importantly, I communicate with all the investigators in the trial at hospitals in the trial’s collaborating countries.
Sarah M’Carthy, Clinical Trial Administrator
I support the team in making sure everything runs smoothly with collaborators across participating countries. For example, I ensure that the drugs used in the trial, a mixture of tranexamic acid and placebo (sodium chloride 0.9%)—are securely stored in a temperature-controlled room of between 15-25°C. I manage its shipment to participating countries and sites, using the I’M WOMAN Trial database to allocate the Investigational Medicinal Product (IMP). IMP refers to a drug being studied to assess whether a medical condition improves while taking it. In this case, the trial is studying the effects of tranexamic acid on postpartum haemorrhage.
Giada Susannini, Assistant Trial Manager
I work with principal investigators and the hospital teams recruiting participants to ensure they understand the trial and have all the materials they need. I also maintain the integrity of data collected and patient safety across the sites.
Can you share what working on the I’M WOMAN Trial means to you?
Monica:
When I had my daughter, I had a very long and complicated labour. It’s clear to me that the reason why we both survived is because we had access to all these interventions that were given to us. I was able to go to hospital and be treated there. Many women around the world still die every year because of complications during pregnancy or childbirth. And if they don’t die, many are left with lifelong issues.
Sarah:
This trial addresses important issues related to women at risk of postpartum haemorrhage— an area that requires more attention in research. Being part of a project that has the potential to improve outcomes for women around the world is incredibly rewarding.
Aasia:
There are many areas in our country where maternal mortality is much higher than the average mortality rate of the country. Factors including regional disparities, socioeconomic status and limited access to healthcare facilities, can increase the likelihood of maternal mortality and obstetrical haemorrhage. The I’M WOMAN Trial is pertinent to looking at the effect of TXA on the prevention of postpartum haemorrhage and comparing the various route of administrations.
If the result of the study is positive, it will have a huge impact on maternal health in Pakistan. It will help many vulnerable women giving birth outside healthcare facilities where intravenous TXA administration is unavailable.
Giada:
I’m learning a lot about maternal health. If the I’M WOMAN Trial could make tranexamic acid (TXA) accessible to more women, it has the potential to reduce inequality and give more women access to treatment for PPH.
What led you to work in clinical trials?
Aasia:
As an obstetrician, I witnessed few, but not many, maternal deaths. Most women arrived at our hospital too late. They bled a lot, and we couldn’t do anything to help. It inspired me to work on research pertaining to maternal health and address the different problems women endure globally.
Giada:
Clinical trials allow you to be face-to-face with the research. You see in practice what is working, what is not and how the research is progressing. It’s very pragmatic research, so I feel more connected and closer to an actual result than when I worked in a laboratory.
Monica:
After completing my PhD in biochemistry and neuroscience, I worked as a research scientist. I then transitioned to the pharmaceutical industry, driven by my desire to apply my knowledge to help alleviate and cure diseases. While working in drug discovery, I developed a strong interest in clinical trials. It’s a natural extension of my work that allows me to contribute directly to improving patient care.
Sarah:
I chose to work in clinical trials because it’s a way to contribute to life-changing research that has the potential to improve or save someone’s life. The collaborative environment with the teams and being part of the I’M WOMAN Trial have deepened my interest in clinical trials.
What inspired you to work in science?
Giada:
Before joining the I’M WOMAN Trial, I didn’t know much about maternal health. It’s interesting to learn about inequalities and women’s health issues that are often overlooked and under-researched. I also think it’s amazing to contribute to a non-profit trial where the focus is purely on research and improving understanding about TXA, rather than increasing profits for a drug, which is already on the market.
Sarah:
I’m inspired by how various fields of science collaborate to support these advancements. Each role plays a crucial part in driving progress.
Aasia:
I have grown up viewing science as a lifelong opportunity for learning. There is no such thing as stagnation in science – there is always something to work on. I wanted to utilise my scientific knowledge to positively impact and improve the lives of people around me.
Why is it important that more women work in clinical trials?
Sarah:
It’s important to bring diverse perspectives and serve as role models, inspiring others to join the field. Their presence helps address the gender gap and drives inclusivity and innovation.
Aasia:
The fact that around 50% of the world’s population are men, shows how women are underrepresented in research globally, and specifically in clinical trials. The same fact resonates in Pakistan where very few women are working as a clinical trialist [on clinical trials].
More women in clinical research can promote inclusiveness and gender diversity in research. Women can better understand women’s health issues and other issues like maternal and reproductive health than their male counterparts. I don’t underestimate them, but each woman is going through all these issues in their daily life, so it’s very important that women participate in the research.
Giada:
When women are underrepresented in clinical trials it leads to less knowledge on women’s bodies and women’s health.
More women in science may improve research on issues like maternal health and women’s health that are sometimes overlooked. For some women, I think it will help to decrease data inequality. I’m currently reading a book “Invisible Women: Exposing Data Bias in a World Designed for Men” by Caroline Criado-Perez which highlights this.
Monica:
Clinical trials are essential to demonstrate if an intervention is going to be safe and effective.
We need to make sure that women are properly and fairly recognised, particularly when it comes to being included in publications.
Learn more about the I’M WOMAN Trial and WOMAN Trial teams. Find out more about the benefits of administering intramuscular TXA to reduce severe bleeding after birth.
