The ON TRACK Network Edion 21 ON TRACK News Congratulaons to all involved in the Australian Placental Transfusion Study (APTS) - WINNER of the Australian Clinical Trial of the Year 2018. This is a huge achievement—up against disciplines across the whole of medicine. Congratulaons to Jane Alsweiler and her team for being awarded an HRC feasibility grant for the LATTE trial (prophylacc caffeine citrate in late preterm babies: a randomised controlled dose-finding trial), developed at our Trial Development Workshop in 2017. Are you going to the PMMRC conference on 26 June? Don’t forget to register: https://www.eiseverywhere.com/ereg/newreg.php?eventid=316512& Our annual workshop aims to develop promising concepts for clinical trials into collab- orave, mulcentre proposals suitable for submission for compeve grant funding. This month we profile the second of four concepts presented at this year ’s workshop. Dr Ruth Hughes (obstetric physician) and Dr Jo Gullam (obstetrician) from Christchurch pre- sented their proposal for the Prevenng unnecessary intervenon in placental insufficiency trial (PIPIT). The aim of this trial s to invesgate both the economic benefits and potenal risks of introducing a blood test of placental funcon, the S-Flt/PlGF rao, to aid in the man- agement of women less than 37 weeks gestaon with suspected placental insufficiency in New Zealand. A summary from Ruth - Placental insufficiency, which may present as preeclampsia and/or fetal growth restricon, is one of the most common causes of antenatal admission and iatrogenic preterm birth. This condion affects ~10% of pregnant women in New Zealand. However, many more women are admied with suspected placental insufficiency, which can be difficult to diagnose and even more difficult to predict with respect to the opmal ming of birth. The S-Flt/PlGF rao has been proposed as a promising tool to differenate women with placental insufficiency who need close monitoring and early delivery from those at low risk of developing complicaons. The concept of PIPIT was developed during the ON TRACK work- shop and emerged with a 12 month development plan. We were once again blown away by the experse and support pro- vided at this highly recommended workshop. Preliminary protocols for each step of the trial were formed, including an ini- al observaonal study to assess the performance of the test in Māori and Pacific women, a feasibility study to test the pro- posed management strategies surrounding a low, intermediate and high S-Flt/PlGF rao, and a future naonal randomised controlled trial. We are currently securing ethical approval and funding for the observaonal study. Local consumer repre- sentave feedback for the trial proposal, name and logo was resoundingly posive. Thanks to the ON TRACK stascian, Thomas Lumley, for coming up with the trial acronym - a pipit is a NZ nave bird that walks rather than hops! [email protected]The ON TRACK Network May 2018 Welcome to the May edion of the ON TRACK Network newsleer The ON TRACK Trial Development Workshop - Concept Summary
Transcript
The ON TRACK Network
Edition 21
ON TRACK News
Congratulations to all involved in the Australian Placental Transfusion Study (APTS) - WINNER of the Australian Clinical Trial of the Year 2018. This is a huge achievement—up against disciplines across the whole of medicine.
Congratulations to Jane Alsweiler and her team for being awarded an HRC feasibility grant for the LATTE trial(prophylactic caffeine citrate in late preterm babies: a randomised controlled dose-finding trial), developed at our Trial Development Workshop in 2017.
Are you going to the PMMRC conference on 26 June? Don’t forget to register:
Our annual workshop aims to develop promising concepts for clinical trials into collab-orative, multicentre proposals suitable for submission for competitive grant funding. This month we profile the second of four concepts presented at this year’s workshop.
Dr Ruth Hughes (obstetric physician) and Dr Jo Gullam (obstetrician) from Christchurch pre-sented their proposal for the Preventing unnecessary intervention in placental insufficiency trial (PIPIT). The aim of this trial s to investigate both the economic benefits and potential risks of introducing a blood test of placental function, the S-Flt/PlGF ratio, to aid in the man-agement of women less than 37 weeks gestation with suspected placental insufficiency in New Zealand.
A summary from Ruth - Placental insufficiency, which may present as preeclampsia and/or fetal growth restriction, is one of the most common causes of antenatal admission and iatrogenic preterm birth. This condition affects ~10% of pregnant women in New Zealand. However, many more women are admitted with suspected placental insufficiency, which can be difficult to diagnose and even more difficult to predict with respect to the optimal timing of birth. The S-Flt/PlGF ratio has been proposed as a promising tool to differentiate women with placental insufficiency who need close monitoring and early delivery from those at low risk of developing complications. The concept of PIPIT was developed during the ON TRACK work-shop and emerged with a 12 month development plan. We were once again blown away by the expertise and support pro-vided at this highly recommended workshop. Preliminary protocols for each step of the trial were formed, including an ini-tial observational study to assess the performance of the test in Māori and Pacific women, a feasibility study to test the pro-posed management strategies surrounding a low, intermediate and high S-Flt/PlGF ratio, and a future national randomised controlled trial. We are currently securing ethical approval and funding for the observational study. Local consumer repre-sentative feedback for the trial proposal, name and logo was resoundingly positive. Thanks to the ON TRACK statistician, Thomas Lumley, for coming up with the trial acronym - a pipit is a NZ native bird that walks rather than hops!
Welcome to the May edition of the ON TRACK Network newsletter
The ON TRACK Trial Development Workshop - Concept Summary
The ON TRACK Network
Multicentre Trials currently
recruiting in NZ
Some concerns have been raised that the use of aspirin may increase the incidence of placental abruption and/or antepartum haemorrhage (APH).
This systematic review and meta-analysis evaluates the effect of aspirin, prescribed for the prevention of preeclampsia, on abruption and APH related to gestation of initiation and drug dosage. A total of 20 studies and 12,585 participants were included (10 studies and 3147 participants for doses ≥100mg).
Results: The use of ≥100mg aspirin commencing before 20 weeks was not associated with a change in the risk of abruption or APH (RR 0.99, 95%CI 0.57-1.73). Analysis by gestation at initiation of therapy (≤16 weeks and 16-20 weeks) found no difference in risk of abruption or APH in either group but a significant difference in effect between groups, possibly suggesting that earlier initiation may reduce abruption or APH.
What does this mean for practice: Continue to recommend and prescribe aspirin to women at high risk of preeclampsia and SGA without concern that you are increasing risk of abruption and APH.
GEMS: Gestational Diabetes Mellitus Study of Detection Thresholds Which threshold for the OGTT is best for the health and well-being of mums and babies?
The GEMS Study is comparing the effect on mothers and babies health of two different criteria for the oral glucose tolerance test (OGTT) for diagnosing gestational diabetes (GDM): the current NZ thresholds versus the slightly lower International Association of Diabetes in Pregnancy Study Group thresholds. The 2014 Ministry of Health GDM guide-lines recommend that pregnant women be offered participation in GEMS as one of their options for pregnancy screening for diabetes.
All women giving birth within Counties Manukau and Auckland DHBs, with a singleton pregnancy and without prior history of GDM or diabetes are eligible to participate. The primary outcome is large for gestational age, with additional maternal and infant secondary health outcomes being collected. Economic analyses assess the costs of these two diagnostic thresholds, which will be valuable for guiding health policy. Over 2100 women have generously participated in GEMS so far, taking the study to over halfway through recruitment; given a total of 4158 participants needed.
For further information on GEMS, go to http://www.liggins.auckland.ac.nz/en/for/thecommunity/gems-study.html. For the 2014 MoH GDM guidelines, take a look at https://www.health.govt.nz/publication/screening-diagnosis-and management-gestational-diabetes-new-zealand-clinical-practice-guideline. To contact the Principal Investigator Professor Caroline Crowther or the GEMS team, please email [email protected].
GEMS
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Ministry of Health guideline: Diagnosis and treatment of hypertension and pre-eclampsia in pregnancy in New Zealand (2017) already distributed to clinical leaders at each DHB and available on MoH website within the next few weeks. NZCOM/RANZCOG (NZ) statement: Guidance regarding the use of low-dose aspirin in the prevention of preeclampsia in high risk women: https://www.midwife.org.nz/quality-practice/practice-guidance/multidisciplinary-guidelines/ SOMANZ Guidelines for the Management of Hypertensive Disorders of Pregnancy 2014 (Updated
June 2015) https://www.somanz.org/guidelines.asp
The effect of aspirin on conditions of uteroplacental insufficiency, including preeclampsia and fetal growth restriction/small for gestational age, has been investi-gated in a large number of wide ranging trials.
Consequently it is now recommended as standard practice to prescribe women at high risk of these conditions (based on clinical risk factors) 100mg aspirin from 12 to 36 weeks of pregnancy. Aspirin should be taken at night and ideally started before 16 weeks gestation (although there is still likely to be benefit in commencing treatment up to 20 weeks).
These recommendations are included alongside others in the newly released NZ Ministry of Health guidelines Diagnosis and treatment of hypertension and pre-eclampsia in pregnancy in New Zealand. We recommend these guidelines to you.
Roberge et al (2018) AJOG doi.org/10.1016/j.ajog.2017.12.238
