Helping mothers with postpartum anaemia

Statistical support

Project overview

Working with our statistican on data analysis, randomisation and setting up a trial database.

Data analysis

Data management

Interpreting descriptive data

Randomisation tables

PhD student Esther Caljé worked with the HHRS Platform team to help interpret the data from two studies looking at ways of treating postpartum anaemia – a condition that affects approximately one-third of mothers in the weeks after birth in New Zealand.

Working as a midwife in the birthing unit at Christchurch Women’s Hospital, Esther Caljé encountered many women struggling with postpartum anaemia. It was a problem she had experienced herself as a mother with a newborn baby, and it inspired her to take more notice clinically of what was happening.

“There were so many surprising gaps in the evidence for such a common problem. Even though we were having a number of women every day on the postnatal ward with postpartum anaemia, I could see there was, and still is, this uncertainty in how to treat them.”

Getting started

Esther did her Masters on the management of anaemia and iron deficiency in pregnancy, then later honed her research to concentrate on postpartum anaemia. She had some initial setbacks with grant funding and supervisory support. Then she met Liggins Professor Katie Groom who encouraged her to take her concept to the ON TRACK Trial Development Workshop which developed the basis of her research proposal, and formed a multidisciplinary team to work together. In 2020 Esther got an HRC grant and began her PhD at Liggins.

“That was huge. I realised it’s not just having a great idea, it’s about having a team of the right people to support you with that idea.”

Esther discovered there was no research on postpartum anaemia at all in New Zealand. She started with an observational study looking at six months of retrospective data and lab test results from Counties Manukau, Waikato and Canterbury. This enabled her to quantify the problem: testing and practice was variable, some women were getting intravenous iron (IV-iron), some were getting red blood cell transfusion (RBC-T), some were getting both, and some were getting neither.

Working with our statistician

At this point in her research, Esther began working with statistician Zeke Wang from the HHRS team.

“Zeke came in at a point where I was struggling a little bit with the analysis because there was so much data. The quality of the data wasn’t particularly great, and it was challenging for me to sift through A, the data and B, how I was going to hone what we were trying to achieve. He guided me how to do the analysis, and how to interpret the descriptive data to guide that analysis.”

“Zeke was really great at listening to my clinical interpretation of the data and trying to help make sense of it, saying ‘this could be worth looking at’, whilst sticking to our objectives.”

Getting the pilot trial underway

After the observational study and a systematic review, Esther and the HHRS team worked together to set up the data management for the FIT (Fatigue after Infusion or Transfusion) Pilot Trial and Feasibility Study at National Women’s, Waikato and Christchurch Women’s Hospitals. The HHRS team supported the pilot trial to assess the feasibility of a future randomised controlled trial to answer the question: “Is IV-iron alone a safe and effective alternative to IV-Iron and RBC-T combined, or RBC-T alone, for clinically stable women with moderate-to-severe postpartum anaemia?”

The FIT Pilot Trial and HHRS teams aimed to randomise 20-40 women across three Te Whatu Ora areas into three treatment groups: IV iron; RBC-T; IV iron and RBC-T. The HHRS team generated three randomisation tables for each of the three Te Whatu Ora areas, and when the research personnel entered the trial participant’s NHI number into the REDCAP database, they were automatically assigned to an intervention group.

“The numbers were small, but the structure was the same as for a bigger trial. It had to be done 100% correctly.”

The study also included surveys from women about fatigue, depression, baby-feeding, and why they did or didn’t consent to being randomised, along with surveys from health professionals and research personnel, so there were many different data points.

Working together as a team

“I found the team were so great to work with. It really felt like a team effort. They were respectful of what I knew clinically, and supportive and non-judgemental about what I didn’t know about setting up a trial database.”

The FIT Pilot Trial and Feasibility Study showed that a larger trial was possible. The HHRS team has recently helped Esther to put in an Expression of Interest to HRC for a bigger trial – the Mama FIT trial – and are delighted to be supporting Esther through the process.

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