Greetings! It is with great excitement that I write this update. Ever since my team secured authorization from the Ghana FDA on August 14th, 2015 to conduct our clinical trial in Ghana, things have been moving at a lightning pace.
While I settled in to my second year of medical school back in Halifax, Dr. Jerry Coleman, our Principal Investigator at the Korle Bu Teaching Hospital, conducted some final meetings with his team in late August and early September. On September 7th, 2015, Dr. Coleman and his team successfully launched the Ghana PrenaBelt Trial – a double-blind, sham-controlled, randomized controlled trial investigating maternal back sleep in late pregnancy as a potential modifiable risk factor for stillbirth and low birth weight.
Dr. Coleman’s clinical team – made up of four midwives – is working daily and diligently in the antenatal care clinic to invite, screen, consent, enroll, randomize, and interview participants. It is a colossal task, and they are doing an exemplary job! During the first week of the trial, the team recruited two participants per day on average. By the second week, the average was four participants per day. I am happy to announce that the team has reached our first milestone of 50 participants recruited! Given that our target sample size is 200 participants, recruitment is 25% complete. The participants are eager to use the PrenaBelt every night. Family are engaged too – several participants have reported that their husbands are encouraging and reminding them to wear the PrenaBelt every night! A special thanks to our midwives: Josephine Kwaw, Rose Quartey, Jemima Marfo, and Joyce Dodoo.
Dr. Coleman and I have been having weekly meetings via Skype to debrief on progress and discuss any issues. He has expertly managed everything related to the trial and team to date – props to him! Maxfield Okere is our Data Lead in Ghana. Maxfield has been remarkably proficient in managing all the data related to the trial. The data team is completed by my Project Coordinator in Halifax, Jesse Wells (GIRHL), and our newest addition to the PrenaBelt team, Sarah MacRitchie (GIRHL). A hearty thanks to the data team!
My co-investigator and mentor, Dr. Heather Scott (IWK Women’s Health Centre), visited the team at the trial site in Ghana from September 26th through the 30th, 2015. The visit was of mutual benefit. The team was thrilled with the opportunity to meet and get to know Dr. Scott, vice versa. Dr. Scott was able to see the recruitment process from start to finish and work along side the clinical team. Relationships between Ghana and Canada were strengthened and will hopefully continue to grow in weeks, months, and years to come. I am deeply indebted and grateful to Dr. Scott for her alacrity in setting aside the million other things she has going on and travelling almost 8,000 kilometers for this project!
Finally, I am excited for my co-investigator, Dr. Ali Borazjani (GIRHL), as he prepares to visit the team at the trial site in late October through early November. Hopefully, I will have another update for you after Ali’s visit!
This project is supported by Grand Challenges Canada, which is funded by the Government of Canada.
Nurses Josephine and Jemima announcing to a group of patients details regrading the trial during a recruitment session.
Nurse Jemima and Dr. Coleman teaching a trial participant how to properly wear the PrenaBelt.