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COVID-19 in Pregnancy New Zealand Registry
Investigator Group
Lead investigators
Dr Lynn Sadler, perinatal epidemiologist, University of Auckland and Auckland District Health
Board
Associate Professor Katie Groom, maternal fetal medicine subspecialist, University of Auckland
and Auckland District Health Board. ON TRACK Network National Executive Committee
(Chairperson)
Associate Professor Nicola Austin, neonatal paediatrician, Canterbury District Health Board.
Paediatric Society of New Zealand (President)
Dr Kasey Tawhara, obstetrician and gynaecologist, Lakes District Health Board. Te Kāhui Oranga
ō Nuku Royal Australian and New Zealand College of Obstetricians and Gynaecologists (New
Zealand Office) He Hono Wāhine (member). Ngāti Raukawa, Ngāti Porou
Co-investigators
Ms Rebecca Hay, research midwife, University of Auckland
Ms Laura Mackay, clinical research coordinator, University of Auckland
Ms Julie Arthur, senior midwife, Hawkes Bay District Health Board. Lead New Zealand Midwifery
Leaders Forum, Midwifery Director
Associate Professor Nicola Austin, neonatal paediatrician, Canterbury District Health Board.
Paediatric Society of New Zealand (President)
Dr Malcolm Battin, neonatal paediatrician, Auckland District Health Board. New Zealand
Newborn Network (Chairperson), Australian and New Zealand Neonatal Network
Dr Sarah Corbett, obstetrician and gynaecologist, Counties Manukau Health
Professor Stuart Dalziel, emergency medicine paediatrician, Auckland District Health Board and
University of Auckland, New Zealand Paediatric Emergency Departments Network (Chairperson)
Dr Matthew Drake, obstetric anaesthetist, Auckland District Health Board. New Zealand National
Obstetric Anaesthetic Leaders Network (Deputy Chairperson)
Dr Leigh Duncan, obstetrician and gynaecologist, Hawkes Bay District Health Board. Te Kāhui
Oranga ō Nuku Royal Australian and New Zealand College of Obstetricians and Gynaecologists
(New Zealand Office) He Hono Wāhine (Chairperson), Taranaki Tūturu
Dr Mavis Duncanson, public health physician and epidemiologist, University of Otago. New
Zealand Paediatric Surveillance Unit (Co-Director)
Ms Alison Eddy, senior midwife. New Zealand College of Midwives (Chief Executive)
Dr Christina Fullerton, consumer. PhD Food Science, University of Auckland. Postharvest scientist
Plant and Food Research, Auckland
Ms Kass Jane, Senior Advisor Maternity, Ministry of Health
Tamara Karu, midwife and childbirth educator, Te Puna Oranga (Waikato District Health Board
Maori Health Unit). Hapu Wananga Kaupapa Maori Antenatal Education (Waikato District Health
Board, Ngāti Taratokanui, Ngāti Tamaterā
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Professor Judith McAra-Couper, senior midwife. Auckland University of Technology, National
Maternity Monitoring Group (Chairperson)
Dr Colin McArthur, intensive care physician, Auckland District Health Board. Short Period
Incidence Study of Severe Acute Respiratory Infection (SPRINT-SARI) Lead Investigator (New
Zealand)
Dr Claire McLintock, obstetric physician, Auckland District Health Board, Australasian Maternity
Outcomes Surveillance Survey (investigator)
Dr Sally Roberts, infectious disease physician, Auckland District Health Board
Dr John Tait, obstetrician and gynaecologist, Capital and Coast District Heath Board, Royal
Australian and New Zealand College of Obstetricians and Gynaecologists (Vice President),
Perinatal and Maternal Mortality Review Committee (Chairperson)
Te Rukutia Tongaawhikau, consumer, National Public Health Leader for Kaiwhakarite Bicultural
Relationships for Problem Gambling Foundation Services and Addiction Leadership Network for
midlands district health boards (member). Taranaki, Araukuuku & Ngā Puhi
Dr Sue Tutty, general practitioner, Local Doctors East Tamaki. Royal New Zealand College of
General Practitioners (representative)
Dr Lesley Voss, paediatric infectious disease physician, Auckland District Health Board
Dr Michelle Wise, obstetrician and gynaecologist, University of Auckland and Auckland District
Health Board. Royal Australian and New Zealand College of Obstetricians and Gynaecologists New
Zealand COVID O&G Network (Co-Chairperson)
Libby Whyte, consumer, licensed cadastral surveyor, Alexandra, Otago
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Management Team
Dr Lynn Sadler, Associate Professor Katie Groom, Associate Professor Nicola Austin, Ms Rebecca
Hay, Ms Laura Mackay and Dr Kasey Tawhara
Contact details
Dr Lynn Sadler T 021535187
E [email address] OR [email address]
A National Women’s Health, Auckland City Hospital, 2 Park Road, Grafton, Auckland 1023
Associate Professor Katie Groom
T +64 9 373 7599 ext 89823 or 0212459622
E [email address]
A Liggins Institute, The University of Auckland, Building 503, Level 2, 85 Park Road, Auckland
Private Bag 92019, Auckland 1142
Associate Professor Nicola Austin
T +64 27 229 0598
E [email address]
A Department of Child Health, Canterbury District Health Board, PO Box 1600, Christchurch 8140
Ms Rebecca Hay
T 027 453 6992
E [email address]
A Liggins Institute, The University of Auckland, Building 503, Level 2, 85 Park Road, Auckland
Private Bag 92019, Auckland 1142, NZ
Ms Laura Mackay
T +64 9 373 7599 ext 81366
E [email address]
A Liggins Institute, The University of Auckland, Building 503, Level 2, 85 Park Road, Auckland
Private Bag 92019, Auckland 1142, NZ
Dr Kasey Tawhara
T 0273229244
E [email address]
A Rotorua Hospital, Corner Arawa Street and Pukeroa Road, Private Bag 3023, Rotorua 3046
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Background
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the pandemic
coronavirus disease 2019 (COVID-19). Only small numbers of births have been reported among
women infected with SARS-CoV-2 during pregnancy and, to date, these are almost exclusively
reports of births to women infected in the third trimester of pregnancy who were severely unwell
including approximately 50% of cases complicated by pneumonia. Within these small case series
and reports a disproportionate number of babies were born before 37 weeks and by caesarean
section.1 Previous influenza epidemics including severe acute respiratory syndrome coronavirus
(SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and influenza A virus
subtype H1N1 (H1N1) were all associated with severe illness and mortality in pregnant women.
As yet, no reliable data are available for rates of SARS-CoV-2 infection in pregnant populations or
on pregnancy outcomes for women, or neonatal outcomes for their infants, affected by COVID-19
in pregnancy whether unwell and requiring hospital admission or for those who remain well and
are managed within the community.
Risk of
in utero or vertical transmission is currently unknown.2 Inconclusive evidence from China
based on IgG/IgM data only in three babies suggests vertical transmission may occur. Previous
data on nine babies with RT-PCR (also from China) suggested no
in utero transmission.3 The risk
of horizontal transmission from mother to newborn baby after birth is also unknown. New
Zealand is taking a pragmatic approach to newborn care after maternal SARS-CoV-2 infection,
encouraging breastfeeding and joint self-isolation of mother and baby with physical distancing
and mask and hand hygiene for contact. This is different from some other countries where babies
have been isolated from their mothers. The safety of each approach is yet to be determined.
Establishing the COVID-19 in Pregnancy New Zealand Registry will allow us to provide New
Zealand specific data on how common COVID-19 in pregnancy is; what are the risks of severe
illness for pregnant women; if there is any effect on unborn babies, such as pregnancy loss or
congenital anomaly if they are infected early in pregnancy, or fetal growth restriction, or preterm
birth if infected later in pregnancy; and what are the risks for the newborn from
in utero infection
or infection at or soon after birth.
Relevant Studies on COVID-19 Infection in New Zealand
The Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trial Group has
commenced collection of COVID-19 data via an international collaboration called the Short Period
Incidence Study of Severe Acute Respiratory Infection4 (SPRINT-SARI) Study. SPRINT-SARI began
in 2016 to establish research preparedness for future pandemics. SPRINT-SARI will collect data
in eight (and possibly a further three) hospitals in New Zealand. Only two of these hospitals are
planning to collect data on all hospital admissions with COVID-19, with most only collecting data
on intensive care unit (ICU) admissions. No collection of data from community managed cases is
currently planned. SPRINT-SARI data includes a limited amount of data on pregnancy, including
gestation at diagnosis/time of admission to hospital, stage of pregnancy (antepartum or
postpartum) at diagnosis of infection, pregnancy outcome (live or still birth), date of birth, viral
testing and results of viral testing of babies of mothers with COVID-19, along with comprehensive
clinical information on ICU admission. Dr Colin McArthur, the New Zealand lead on SPRINT-SARI,
1 Cochrane review of cases reported 26/3/2020; https://cgf.cochrane.org/news/covid-19-coronavirus-
disease-fertility-and-pregnancy
2 Kimberlin DW, Stagno S. JAMA. Published online March 26, 2020. doi:10.1001/jama.2020.4868
3 Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of
COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet.
2020;395(10226):809-815. doi:10.1016/S0140-6736(20)30360-3
4 https://www.anzics.com.au/current-active-endorsed-research/sprint-sari/
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has agreed in principal to share data on pregnant women in New Zealand who are included in the
SPRINT-SARI study.
We are also aware of other potential COVID-19 studies and data collection systems in pregnancy
that are being considered.
The Australasian Maternity Outcomes Surveillance System (AMOSS) was established in 2009 to
provide a surveillance system for selected severe maternal morbidities. Case identification is
performed prospectively with retrospective data collection to allow incidence reporting and case-
control studies. AMOSS is planning to collect data on COVID-19 in pregnancy in some Australian
states (confirmed in New South Wales) and this study could include New Zealand. They are in the
early stages of developing their response, which will follow their usual process, co-opting local
coordinators of the New Zealand Perinatal and Maternal Mortality Review Committee (PMMRC)
in each district health board to collect data. This will provide data retrospectively and so will not
be able to provide contemporaneous information on the developing pandemic of infection in New
Zealand. Dr Claire McLintock, a Chief Investigator of the AMOSS group, and Dr John Tait,
Chairperson of the PMMRC, support a New Zealand specific approach to collection of data about
COVID-19 in pregnancy.
Clinicians and researchers from Melbourne, Australia, are also planning to collect pregnancy data
on COVID-19 in Victoria. They have approached maternal fetal medicine subspecialists in other
states in Australia and New Zealand to contribute state and country data. It is likely that these
researchers will work with AMOSS to create a single COVID-19 in pregnancy reporting/data
collection system for Australian states.
While joining an Australian system may be feasible there are several advantages to New Zealand
having its own registry. These include:
• New Zealand specific methodology to ensure all cases are identified;
• Opportunity to safeguard use of New Zealand data;
• Prioritise equity and Māori;
• Ensure control of data for early reporting and ongoing review to assist in the national
COVID-19 pandemic response;
• Data can be interpreted in the context of New Zealand’s unique maternity healthcare
system and New Zealand’s policies and approach to combat the COVID-19 pandemic.
Any New Zealand specific dataset can be created to be compatible with other international
datasets such as those planned, e.g., in Australia, and those already established, e.g., in the United
Kingdom via the United Kingdom Obstetric Surveillance System (UKOSS), which commenced data
collection on 1st March 2020 but will only include COVID-19 in pregnancy cases where hospital
admission occurred. Ensuring compatibility will allow for a global perspective on COVID-19 in
pregnancy as well as comparisons between countries.
We are also aware of other potential COVID-19 studies and data collection systems for neonates
and children and other relevant specialist groups that are being considered.
The Australian and New Zealand Neonatal Network (ANZNN) was established in 1994 as a
collaboration of all neonatal intensive care and special care units across New Zealand and
Australia. Within New Zealand all secondary and tertiary units providing newborn special care
contribute data. All units provide a core dataset of outcomes to a clinical quality registry to enable
benchmarking and collaborative audit, as well as to facilitate research. ANZNN are currently
planning to extend their dataset to include all admissions to neonatal units of newborns of COVID-
19 positive mothers and/or COVID-19 positive newborns. They do not plan to collect data on
newborns of COVID-19 positive mothers and/or COVID-19 positive newborns who are cared for
on postnatal wards, in primary birthing units or in the community. It is likely that ANZNN will
collaborate with the International Network for Evaluation of Outcomes (iNeo) of Neonates which
will include data from a number of national neonatal networks. Dr Malcolm Battin is the
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Chairperson the New Zealand Newborn Network and a New Zealand representative in ANZNN.
We will work with all New Zealand units to ensure data collection is complimentary and not
repetitive.
The Pediatric Emergency Research Network (PERN), led by Professor Stuart Dalziel, plan to
collect data related to emergency department presentations with SARS-CoV-2 infection in over
50 emergency departments globally, including data from New Zealand. Further Professor Dalziel,
together with colleagues from the New Zealand Paediatric Surveillance Unit will collect data on
all paediatric admissions to hospital with COVID-19 in New Zealand. This University of Otago
group, led by Dr Mavis Duncanson, was established as a national surveillance unit for acute flaccid
paralysis but also aims to facilitate national surveillance of other uncommon childhood
conditions in New Zealand. It is also possible that an infectious disease-led observational study
may be considered but further detail is currently unavailable.
No other groups are currently planning a New Zealand COVID-19 in pregnancy specific study and
no other group is planning to include all newborn infants exposed to and/or infected by COVID-
19 during fetal and/or early newborn life. We plan to continue to collaborate with all groups in
New Zealand working in this space to ensure that data collection is as effective and efficient as
possible, and that where possible safe and effective data linkage occurs to reduce duplication of
effort.
Study Aims
To create a registry of all cases of COVID-19 in pregnancy and the newborn period in New Zealand
to answer these, and other, research questions:
1
What is the incidence of SARS-CoV-2 infection/COVID-19 in pregnancy in New Zealand;
and are there differences in incidence of SARS-CoV-2 infection/COVID-19 in pregnancy for Māori
and non-Māori? Including contemporaneous reporting of cases to support local maternity and
neonatal care responses.
2
What is the natural history of SARS-CoV-2 infection/COVID-19 in pregnancy in New
Zealand, including outcomes for mothers and babies, from infection in early (<20 weeks) and
later (>=20 weeks) pregnancy? Are there differences in outcomes for mothers and babies for
Māori and non-Māori, and if so why? What is the risk of infection in babies by vertical
transmission and horizontal transmission in the first six weeks of life?
3
How do rates of SARS-CoV-2 infection/COVID-19 in pregnancy and its effect on adverse
outcomes (such as maternal death, adult respiratory distress syndrome (ARDS), maternal ICU
admission, and requirement for ventilation, miscarriage, fetal anomaly, preterm birth, fetal
growth restriction, stillbirth and perinatal death) vary by country where onset of widespread
infection occurred early or late, with different approaches to containment, and with different
models of maternity care?
4.
The impact of COVID-19 vaccination on the incidence and severity of SARS-CoV-2
infection/COVID-19 in pregnancy in New Zealand. (Addition October 2021).
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Study Design
This is a
prospective registry study of all cases of probable or confirmed COVID-19, and SARS-
CoV-2 infection, occurring in pregnancy and up to six weeks postpartum in New Zealand,
including outcomes for mother and baby.
Study Population
The registry will aim to include all maternal cases of probable or confirmed COVID-19, and SARS-
CoV-2 infection, that are diagnosed in pregnancy or within six weeks of birth in New Zealand,
including the outcome of the babies of these women.
We will aim to include all cases from the date of first confirmed case in New Zealand (28th
February 2020).
Inclusion Criteria (case definition)
• All women with confirmed or probable COVID-195 or laboratory confirmed SARS-CoV-2
infection during pregnancy and up to six weeks postpartum.
• All newborns born to mothers with COVID-19 or laboratory confirmed SARS-CoV-2
infection during pregnancy and up to six weeks postpartum regardless of SARS-CoV-2
status.
Cases managed in hospital and in the community will be included.
Infection in pregnancy at all gestations will be included (confirmed pregnancy by urine or blood
hCG test and/or ultrasound).
Study Procedures
To enable the establishment and effective use of this registry the study investigator group
includes representatives from the wider maternity community including consumers. To optimise
engagement with Māori, we are working in partnership with members of Te Kāhui Oranga ō Nuku
He Hono Wāhine (Māori women’s health subcommittee of the New Zealand office of Royal
Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG).
To identify
women with SARS-CoV-2 infection both in the community and from hospitals it will be important
to have support from general practice, midwifery lead maternity carers (LMCs), obstetric LMCs
and hospital clinicians. To this end, we have taken advice from, and enlisted as co-investigators,
representatives from the New Zealand College of Midwives (NZCOM), the Royal New Zealand
College of General Practitioners (RNZCGP) and RANZCOG.
Study promotion: The Registry will be promoted to healthcare providers by email via the
appropriate Colleges (NZCOM, RNZCGP and RANZCOG).
We will also generate public awareness through a dedicated webpage on the Liggins Institute
website and via social media. To maximise understanding and interest for Māori we will provide
5 As at 31/03/2020 defined as
•
Probable: A case that meets both clinical and epidemiological criteria where other known aetiologies
that ful y explain the clinical presentation have been excluded, and either has laboratory suggestive evidence
or for whom testing for SARS-CoV-2 is inconclusive.
•
Confirmed: A case that has laboratory definitive evidence of SARS-CoV-2 infection.
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Māori specific messages and ask that they be distributed via Te Rōpū Whakakaupapa Urutā and
Tumu Whakarae (the National DHB Māori General Managers Group) for dissemination to DHB
Māori Directorates.
Case identification and notification: We will use several methods to maximise the opportunity
to include all eligible cases including via DHB clinical leads/nominated contacts, colleges, Lead
maternity carers (LMCs) and consumers.
A REDCap database hosted by the Liggins Institute Clinical Data Research Hub (CDRH) was
planned from the outset to record notification of cases and for later data collection. The provider
quote was greater than $30,000 to host and maintain this database. There were not enough cases
to justify this cost and an initial funding application for the Registry was unsuccessful. The
management team subsequently explored commencing notification and data collection via
hardcopy forms, rather than through a REDCap database (as documented in Protocol V4,
21Aug2020). After consultation and consideration of data privacy, hard copy forms were not
utilised and a series of REDCap databases were established through the University of Auckland
FMHS REDCap. All data has been collected via the electronic REDCap databases. Case notification
is via a REDCap survey, and the permalink to access this is present on the registry website,
information sheet for health professionals, and has been distributed to DHB contacts and the
colleges.
1
Primary care (general practice, midwifery, obstetric) and hospital clinicians will be asked
to notify cases of confirmed or probable COVID-19 or laboratory confirmed SARS-CoV-2 infection
in
pregnancy
via
the
notification
link:
https://redcap.fmhs.auckland.ac.nz/surveys/?s=M9DKWNAYYH. We will work with health
professional colleges (NZCOM, RNZCGP and RANZCOG) and DHBs (via named representatives) to
advertise and promote the Registry and to develop regular reminder systems.
2.
The Registry webpage www.liggins.auckland.ac.nz/covid19 will provide opportunity for
women to self-report SARS-CoV-2 or COVID-19 diagnosis. Contact details of their healthcare
provider (LMC, GP or DHB) will be requested and the research team will make direct contact with
their healthcare provider to commence the notification process.
3.
We will work with other systems that are expected to collect data on COVID-19 cases that
may include or relate to pregnancy, to cross-reference our registry notifications, including:
• district health board (DHB) records;
• the Ministry of Health public health surveillance system (which includes a flag for
pregnancy);
• regional public health services such as ARPHS; and
• ANZNN and the New Zealand Paediatric Surveillance Unit (NZPSU) reporting systems;
to ensure ascertainment of cases is as complete as possible.
We will strive to ensure the notification of cases is straight-forward and is as time-limited as
possible, with the option to include minimum mandatory fields only. We anticipate multiple
notifications per case are likely to occur and will develop the system to accommodate this.
Consent: We applied to the Health and Disability Ethics Committees for a waiver of consent on
the following grounds:
1.
Notification of cases by healthcare workers is not considered research
2.
The research component of this proposal is observational research of only de-identified
routinely collected data.
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3.
All data will be de-identified beyond the notification set, which will only be used for the
purpose of requesting missing and prospective data, and merging data from various sources. No
identifiable data will be included in the dataset for analysis, and no individual data will be
reported. The re-identification key will be carefully protected in a separate secure database at the
University of Auckland.
4.
Collection of consent will be burdensome for individual cases, healthcare providers and
researchers. Notifications will be requested from a large group of providers, and from cases
where contact (including of time, and with paper and electronic devices) is advised to be strictly
limited to essential requirements only in order to reduce transmission of infection. Specifically,
caregivers are currently advised not to handle or store ‘infected’ hard copy materials and should
not share a device to gain electronic consent, and so in practical terms consent could only be
provided verbally.
5.
COVID-19 is a serious and potentially fatal infection that is causing a pandemic of
unprecedented scale and cost to human health, not seen since the influenza pandemic of the early
20th century. Accurate national epidemiological data are urgently needed to plan the national
response to this (and future SARS infections), in order to prevent massive loss of life.
6.
Data collection systems and studies of this type are in existence in New Zealand in the
areas of maternal and newborn health including ethics approval for use of routinely collected
data without participant consent for use of de-identified data (AMOSS, ANZNN and NZPSU).
The use of waiver of consent was declined by the Northern B Health and Disability Ethics
Committee and subsequently a request for use of opt-out consent has been made and approved.
The information sheet for mothers who are included in the Registry (Appendix 1) provides brief
information on the purpose of the Registry, the data that will be collected and ways it will be used.
It is clear that women will not be required to take any additional actions as a consequence of their
data being included. It includes information on how to request to opt-out- of inclusion in the
registry as well as contact details for the research team to request a copy of individual data and
published results. This information sheet will be made available to all healthcare providers for
distribution to all women who met the eligibility criteria at the time of notification to the Registry.
It will also be accessible from the Registry webpage.
Dataset: The investigators have reviewed the data collection reporting forms from the
Melbourne COVID-19 in pregnancy and the UKOSS surveillance datasets to inform the data
collection instruments in this registry so that the findings from studies using this registry can be
compared internationally. Addition October 2021: addition of COVID-19 vaccination status
including dates and type given.
Data collection: Web based REDCap databases managed by Laura Mackay and Rebecca Hay,
Liggins Institute, and hosted by The University of Auckland, will be used for notification of cases
and data collection (Figure 1).
Case notification. The notification dataset will include identifiable personal details of women and
their babies, only available to the researchers for the purpose of later extraction of routine data
(from the LMC, clinical notes, or routine datasets) and to exclude duplicate notifications. This
dataset will also hold details of the notifying clinician and the LMC (if known at that time). The
research team will negotiate with each DHB via the New Zealand Midwifery Leaders Forum to
identify an appropriate nominee from each DHB who may be, for example, the PMMRC local co-
ordinator (as per current mechanism for maternal morbidity data collection for AMOSS) or the
local Maternity Quality and Safety Programme (MQSP) Co-ordinator.
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Case notification will include a limited number of data items. The notifying clinician will be asked
to provide identifying data for the woman and baby/babies (if applicable), and the woman’s
estimated date of delivery (EDD).
De-identified Registry Database
1.
Notification – Registry Data. The LMC, notifying clinician or nominated DHB delegate will
be sent a secure electronic REDCap survey link to provide data relating to the diagnosis of COVID-
19, the woman’s medical history and pregnancy risk factors. Notifiers will be asked to provide as
much information as possible and data collection will be supported by the research team if
required. The email request will include contact details for the research team if assistance is
required.
2.
Pregnancy Outcome Data. The LMC, notifying clinician, or the nominated DHB delegate
will be contacted via email after the expected time of birth (EDD). They will receive a secure
electronic survey link for reporting of the remaining data related to the pregnancy and birth. All
data items are routinely included in standard maternity clinical records/datasets. The email
request will include contact details for the research team if assistance is required.
3.
Six Week Postpartum Data. A further email with a secure electronic survey link will be
sent to the LMC, notifying clinician or nominated DHB delegate six weeks post birth/pregnancy
completion. The email request will again include contact details for the research team if
assistance is required.
Non-responders to email requests for data collection will be contacted by follow up email or a
telephone call from the research team 1-2 weeks after the initial request.
Data relating to babies admitted to a neonatal special or intensive care unit will be extracted by
the research team, or with assistance from the neonatal units, using the recently developed
ANZNN COVID-19 data form to avoid duplication of data collection and additional burden on
neonatal clinicians.
Data for women admitted to Intensive care will be extracted by the researchers or requested from
the SPRINT-SARI (ANZICS) team.
If outcome data cannot be found via GP, LMC, or hospital sources, a request will be made for data
from the Ministry of Health national maternity (MAT) or hospital discharge (NMDS) datasets for
women notified as having COVID-19 in pregnancy.
Only routinely available data will be included in the Registry. No extra tests outside of routine
care will be requested for this study.
Sample Size
At this time it is difficult to estimate the impact of COVID-19 in New Zealand. There are
approximately 60,000 births per year in New Zealand. If SARS-CoV-2 infected 10% of the
population and this included women of reproductive age, this might include 6,000 women. If 1%
of people were infected, this would include 600 women.
Confidentiality and Data Security
Data will be managed by the Liggins Institute, University of Auckland. Oversight of data security
and access will be managed by the Registry Data Governance Group (Appendix 2).
Individual privacy will be protected by the use of three separate REDCap databases which will be
stored on a secure password protected server at the University of Auckland. Identifiable personal
information of women and their babies will be collected in order to facilitate follow-up data
collection through to six weeks postpartum, and to exclude duplicate notifications.
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After removal of duplications, each case will be assigned a unique registry number and an
identification dataset will be created consisting of maternal name, NHI, date of birth, registry
number and caregiver contact details. Cleaned de-identified notification data will be transferred
to a third registry database identifiable only by the unique registry number. The electronic follow-
up surveys will be sent by email to LMC, notifying clinician or nominated DHB delegate via the
identification dataset and will include a secure one-time link to the outcome form in the de-
identified registry database. All transmitted data will be encrypted. This system will enable
collection of fully de-identified outcome data and for the correct merge of later data with the
correct case in the de-identified registry database.
Participant privacy and the re-identification processes will be closely controlled. Access to
notification, identification and de-identified registry data base will be limited to select members
of the research team, including the Registry Data Governance Group and research staff appointed
by the Data Governance Group.
Extracted data files will be fully de-identified. Study presentations and publications will contain
only summary data and individual participant data will not be reported. The research team will
be responsible for data access. Identifiable data will not be released to any third party for any
purposes, including for the purpose of future research.
At the completion of the study, all electronic registry data will be permanently digitally archived
and accessible only to the lead investigators. Any remaining hard copy records will be stored in a
locked cabinet in a secure office and will be accessible only to the lead investigators and research
staff appointed by the Data Governance Group. Records will be retained for a minimum of 10
years after the age of majority. If a data sharing option is mandated by the publisher, only de-
identified data will be released and its use will be strictly controlled by a data sharing agreement
overseen by the Data Governance Group.
Data Analysis
The frequency of data review will be dependent on case numbers. Data will be used to inform the
approach to COVID-19 among pregnant women in New Zealand and to inform women. These data
will be shared with the investigators, Colleges (RACGP, NZCOM, RANZCOG) and the Ministry of
Health.
During and at the end of the study, to be determined by the birth of all babies of women with
COVID-19 in pregnancy and after such time that COVID-19 is significantly reduced in New
Zealand, data will be compiled for peer reviewed publication.
An equity analysis will be undertaken if possible, contingent on numbers of cases among groups
by age, ethnicity, and socioeconomic advantage, to determine whether there are differences in
severity of disease and outcome.
A detailed statistical analysis plan will be developed.
Responsiveness to Māori
It is, as yet, unclear if there may be any difference in rates of COVID-19 in pregnancy or its effect
on pregnancy outcome, for Māori and non-Māori. Assessment of this is one of the objectives of
this study.
Issues of special importance to Māori for this study include waiver of consent for inclusion and
use of data, data security, and data governance. The team of study investigators includes
representatives of Te Kāhui Oranga ō Nuku He Hono Wāhine (Māori women’s health
subcommittee of the New Zealand office of RANZCOG) and Māori clinicians (midwives and
obstetricians), Māori health researchers and wāhine Māori (consumers).
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Governance
The team of Registry investigators has been selected with consideration of key stakeholders
including consumers, Māori health representatives, clinicians, researchers and collaborator
groups. We have consulted with:
• The Ministry of Health
• He Hono Wāhine, a subcommittee of Te Kāhui Oranga ō Nuku (the New Zealand
Committee) of the Royal Australian and New Zealand College of Obstetricians and
Gynaecologists
• Te Kāhui Oranga ō Nuku (the New Zealand Committee) of the Royal Australian and New
Zealand College of Obstetricians and Gynaecologists
• New Zealand College of Midwives
• Royal New Zealand College of General Practitioners
• New Zealand Perinatal and Maternal Mortality Review Committee
• New Zealand National Maternity Monitoring Group
• Paediatric Society of New Zealand
• New Zealand Newborn Network
• Australian and New Zealand Neonatal Network
• New Zealand Paediatric Surveillance Unit
• Australian and New Zealand Intensive Care Society
• Perinatal Society of New Zealand
• New Zealand Midwifery Leaders Forum
• New Zealand Clinical Directors Forum
The Registry Data Governance Group has been established to provide oversight of data security
and to consider applications for data access (Appendix 2).
Consumer Representation: Consumer input is vital in the design of the Registry, to inform
decision making on request for use and sharing of data, to assist with raising public awareness of
the Registry and to inform plans for dissemination of findings. Consumers have been included in
the investigator team.
Ethics and Locality Approval
Ethics approval will be obtained from the Health and Disability Ethics Committee prior to
commencement of any data collection.
The study will be conducted in line with the Principles of the Declaration of Helsinki (1996), with
the International Conference on Harmonisation and Good Clinical Practice guidelines, and in
compliance with the Protocol.
Locality approval will be sought from the Liggins Institute at The University of Auckland.
Publication and Dissemination of Findings
We will develop a publication and dissemination plan which will include regular reporting and
later study reports and peer reviewed publications. We will ensure all reports are available
publicly via the Registry webpage and other avenues and shared with Te Rōpū Whakakaupapa
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Urutā (the National Māori Pandemic Group) and Tumu Whakarae (the National DHB Māori
General Managers Group) for dissemination to DHB Māori Directorates.
Funding
We will seek funding to support the ongoing costs of maintaining the Registry and subsequent
data cleaning, linkage and analysis. Seed funding is available to support this project through
cluster funding from the Hugo Charitable Trust that supports research activities for Associate
Professor Katie Groom.
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Positive test for SARS-CoV-2 and/or clinical diagnosis of
COVID-19 in pregnant woman or within six weeks of birth
Case Notification: Responsible clinician notifies case
via REDCap survey:
Data to Ministry and
•
colleges on numbers
Woman’s details
and demography of
• LMC and notifier details
cases
• Estimated date of delivery (EDD)
• Baby’s details (if applicable)
Cross-reference with Public Health Surveillance data to
identify any missing cases; and to check confirmed cases
Notification – Registry Data: request sent to LMC/
notifier/DHB designated nominee asking for:
• Details of infection episode
• Medical history (respiratory, cardiac, renal)
• Obstetric history (previous perinatal death,
ase
b
preterm birth)
Baby admitted to SCBU/NICU:
ata
Request information from
y D
SCBU/NICU where admitted
Pregnancy Outcome Data at expected date of birth
tr
(ANZNN dataset)
(EDD): request sent to LMC/notifier/DHB designated
egis
nominee asking for
R
d
• Pregnancy outcome details
• Newborn admission to SCBU/NICU?
tifie
Woman admitted to ICU:
en
• Woman admitted to ICU?
Request data from ICU where
id-
admitted or SPRINT-SARI
De
Six weeks post birth: request sent to LMC/GP/DHB
dataset
designated nominee asking for
• Newborn status at 4-6 weeks postpartum
• Woman admitted to ICU?
Data unable to be found on pregnancy outcome:
Request to Ministry of Health for MAT (national
maternity) and NMDS (hospital discharge) data
De-identified data set for analysis
Figure 1: Flow of information COVID-19 in Pregnancy New Zealand Registry
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APPENDIX 1: The COVID-19 in Pregnancy New Zealand Registry INFORMATION SHEET
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APPENDIX 2: The COVID-19 in Pregnancy New Zealand Registry DATA GOVERNANCE CHARTER
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