Here women and parents tell their stories of participating in, or agreeing for their babies to participate in, clinical trials. If you have a story to share we would love to hear from you. You can submit your story here.
Vanessa was quickly approaching the birth of her son when she decided to take part in the C*STEROID Feasibility study. Here she tells her story.
I found out about the possibility of taking part in research whilst pregnant when I received information in the mail and via email about the C*STEROID feasibility study. At that stage I wasn’t sure I was going to have a caesarean section, so I didn’t decide to go ahead with participating in the study until about a week before I had my little boy, Theo.
I was quite interested in taking part after reading information about the study, but I also discussed it with my obstetrician, and he was very positive about it. His opinion (from my memory) was that if anything, the checking of babies’ blood sugars after birth (a key part of the study) can only be helpful. We discussed how babies that are in higher risk groups (high/low birth weight, mums with gestational diabetes etc.) get tested, and that if blood sugars are so important for babies why are we not routinely testing. Potentially that’s something this study could find out too. So, for us it was a way we could have more checks that our little one was getting the best possible start.
At first, I was a little hesitant about the study’s steroid injections but as I discussed with my obstetrician and confirmed it’s a steroid that is already in use; after realising that it is just being used in a different way, I became confident that I did want to participate.
All the research staff I was in contact with were very accommodating and friendly, especially since I only decided to participate very close to the end of my pregnancy. I also liked the fact that taking part gave me something to do while I was off work!
I’m very interested to see the results of this study and I think there will be findings to help babies born in the future. For our family, our little man ended up on the lower end of the weight scale at birth (he’s now thriving!) and he had low blood sugar results, so instantly it was beneficial for us to have taken part. We also had support from the researchers and staff on the ward every hour for the first hours of his life to ensure he got back on track. We then had help from research staff with feeding and general positive support and encouragement in caring for our newborn. I’m hoping that when it comes time for baby number two, we can take part in research again!
During her pregnancy Kathleen took part in the C*STEROID Feasibility study. Here she tells her story of participating in clinical trials research.
I remember receiving a couple of emails and maybe something in the post about the study, I can’t recall too clearly now. With the first email, I’m ashamed to say I didn’t pay it much attention as I was busy and not really thinking yet about the delivery of my baby! But when I was contacted again in my third trimester and closer to the delivery date, for whatever reason it grabbed my attention. I spoke to my obstetrician about it and she knew about the study and said it was run by reputable people. She also talked me through what it was about. I then spoke to one of the research staff to find out more.
My doctor having confidence in the people running the study and assuring me that it was well run influenced my decision to participate. My sister in law had also just delivered about 4 months before I did and both she and my brother are doctors. I asked them if they knew about the study and it turned out she had participated. That also helped alleviate any concerns I had. My only concern was that I didn’t want to put my baby at undue risk, but I was comforted by the fact the steroid injections being tested in the study were already routinely administered during pregnancy for premature babies to help them.
Although I was not overly keen from the outset as I was busy thinking about other things, once I focused my attention on it (again I’m sorry to say!) and spoke to my doctor and sister in law I became increasingly interested in taking part. I didn’t have reservations per se at the start – more just wanting to find out what it was about and the risks. I was quite keen to help if I could without putting my baby at risk. I think between me turning my mind to it and making the decision it was just a day or two – and most of that time was to speak to all involved. Once I found out about it and obtained the necessary information it seemed an easy way for me to contribute without any real risk of harm to my baby.
My experience of taking part is that it was easy, pleasant and I’m happy to have been able to help. I needed to make two trips to get the steroid injection before my caesarean section, but it was close to my obstetrician and place of work, so I managed to fit it in without too much inconvenience. The midwife who tested my baby’s blood sugar level after she was born was also very responsive, so we communicated well to ensure the blood test was done before a feed without too much effort.
I’m happy to have been able to help and I’m looking forward to finding out the outcome of the research in due course. I think I’m definitely more open to other studies now that I have done this and had a positive experience. I thank those involved for their important work!
Billie is a proud mum who has participated in a couple of clinical trials while pregnant. Here she tells us of her experience and explains why as a mum she was motivated to get involved in research.
Back in 2016, when I was child-free and didn’t have a single grey hair, I was scrolling through Facebook and a sponsored post popped up looking for pregnant women to be involved in a clinical trial. It was for the NIPPER trial, which involved taking a supplementary drink during pregnancy (very similar to leading pregnancy vitamins, with a couple of additional supplements thrown in). The whole thing looked very beneficial, so I had a chat with my husband, we registered our interest and our participation in research went from there.
Given New Zealand’s relatively small size, I’ve always been impressed at what we’ve been able to contribute to clinical research globally concerning the health and wellbeing of babies. For example, look at the findings from the New Zealand cot death study in the 1980’s, which resulted in changes to baby sleeping habits internationally. So, when I saw the opportunity to contribute to ongoing research, I really felt compelled to be part of it.
With my first son, Archer, we had several appointments throughout the pregnancy where my bloods were checked, and we also had additional scans. Being my first pregnancy, this was all very reassuring. When I became pregnant with my second son, Beau, I received some information in the mail regarding studies that were currently running from the Liggins Institute at the University of Auckland. I had a follow up phone call from one of the research midwives and we discussed the C*STEROID feasibility study. Although by this point, I felt as though I knew and trusted the research team, I still ran this past my Obstetrician who was extremely supportive of me being involved. To have the approval of an independent medical professional is always reassuring.
The C*STEROID feasibility study was a lot less time consuming than the NIPPER study, consisting of only two appointments just before birth. However, we still definitely benefitted from the additional care we received through being involved in a research study.
Following Beau’s birth, we were visited by research midwives from Liggins to take his blood sugar levels. It was picked up that he was slightly hypoglycaemic where his blood sugar (or glucose) was low, which he probably wouldn’t have been tested for outside of the study. But even more importantly, our research midwife picked up that Beau was struggling with his breathing and rallied the hospital staff to get Beau transferred to NICU for the additional care he needed. I really can’t express how grateful I am to have had her there to help Beau when he needed it.
Being involved in a clinical trial not only gives you the altruistic feeling of being involved in something for the greater good, but also (more selfishly) gives you additional checks and monitoring which you might not get otherwise. Pregnancy and childbirth can be a stressful time, and if you’re a natural worrier like I am, having an additional set of eyes monitoring your little one can be a great comfort.
I’m proud that my two boys have been able to contribute. By participating in research my whānau has contributed to improving the lives of mums, and to saving the lives of future babies.
Jessica participated in a clinical trial while she was pregnant. Read on for her story as to why she is happy she took up the opportunity to get involved, and what further opportunities research has opened for her.
During my pregnancy with our first-born son I was approached by my midwife to participate in the GEMS study. I knew nothing of the study and even less about being a research participant. A few things led me to consider participating. My older sister had struggled with gestational diabetes with both of her pregnancies and I felt that anything I could do to contribute to knowing more about gestational diabetes, especially within New Zealand, would be helpful. I also remembered my mum participated in a research study in the 80’s when I was a baby, I obviously don’t remember participating but I do remember being told about it as a child and feeling a sense of pride knowing that I had contributed to something that would benefit future babies. Lastly, the GEMS study made sense and did not require a lot from me. Standard antenatal care included testing for gestational diabetes and other than a few questionnaires, participating was not difficult or time-consuming.
Taking part in the GEMS study was a great way to dip my toes in the water of research participation. The research team were lovely and kept me well informed. After meeting some of the research midwives and clinicians I was invited to attend this year’s ON TRACK Network trial development workshop as a consumer. The workshop was so interesting. I enjoyed seeing how research projects evolve and was happy that as a mum I was invited to give my input about research designs. My participation in the workshop led to me joining the Forum’s Advisory Committee with other mums to help ensure those most impacted by research have their voices heard.
I think as a naturally curious person I was inevitably drawn to the research community, especially in the wild first days with a newborn. Our son was born at 36 weeks and had great difficulty feeding. Though we didn’t participate in any studies around late premature infant feeding I recall seeing one later and thought it would have been helpful to join. I would like to know the findings as I would love for future mums struggling to feed their newborns to have access to better guidance to refer to during those difficult times.
As a social worker I have always been aware of how important research is – how can you recommend an intervention, a solution, a therapy, without first knowing if it works? Studying these big questions is vital work, and becoming a mum solidified this for me. I now undertake research in my own field of work and am always appreciative of the people and whānau who so generously share parts of their parenting journeys with me.
I like to think that contributing to research in New Zealand has come full circle for me and my whānau. We have certainly benefitted along the way from those who came before us and contributed to studies that have helped us to better understand our babies and their needs. And now I can tell my children when they’re older, “did you know, you helped researchers better understand gestational diabetes? That’s you, in those studies. You helped develop that knowledge and now mums and babies are better off for it.”
Katie reflects on her family’s experience of being approached for her premature baby to participate in research.
After having one very early baby and 102 days in NICU, we want to help any other family that may go through a similar journey and right from the get go, despite all the stress, we were completely open to being involved in anything that could both help our baby as well as future babies going through this rollercoaster of extreme prematurity and NICU.
We were in the delivery suite; my waters having broken at 23 weeks and 1 day with discussions around labour becoming quite stressful due to the extreme prematurity of our baby and her breech position. I recall the first research being asked about as a ‘no brainer’’ – the APTS trial (Australian Placental transfusion Study).
We were informed the trial had already been done on a large number of full-term babies throughout Australia and New Zealand and now they were looking at preterm babies. We were approached gently, without pressure and with clear, black and white information – we would either be randomised to have delayed cord clamping (1 minute) at the birth or not and if our baby was struggling it would be abandoned and clamped immediately so she could be taken to resus. We were informed quickly we’d been randomised to the delayed clamping group and in an extremely tense theatre situation just over 24 hours later, our tiny barely viable baby received this delayed clamping (in what seemed like the longest minute of our lives!) and I often wonder if this has helped her survive and do so damn well!
In those early, harrowing days following, among the fear and concern with having such an early baby, we were approached to take part in both the PROVIDE/protein trial and the HINT2/hypoglycaemia and insulin or blood sugar trial. We were so exhausted and unable to process whether there were any absolute clear positives for our baby as an individual for the protein trial, thus opted out. We felt no pressure whatsoever from the doctor for making this decision and we moved on. We did question our decision once or twice, but also had to put our baby first and being where we were at the time, we weren’t 100% certain it would be of help or not for our individual situation.
The HINT trial, however, we agreed to, mainly because we knew we could withdraw at any time. At some stage in the piece we did stop, but were reassured by one of the researchers that we had already helped provide what sounded to be valuable measurements and information to assist in their research in one small way, which was all we felt we could do as parents.
The other research I recall spending some time with one of the researchers on was more qualitative – considering the social and emotional aspects of being a parent with a baby in NICU. Again, we were approached extremely gently, with no feeling of pressure or necessity to take part. Our baby’s daily NICU routine and what we had on for the day in general was fully respected to allow a time for us to speak with the researcher that worked with us without stress or worry and they listened patiently, with what appeared to be interest and with empathy.
Any part mothers or parents of babies can play in helping research that aims to improve the health of mothers and babies across New Zealand is vital. We should be proud as such a small country we are making such exciting progress in this field.