JMIR RESEARCH PROTOCOLS Lawton et al

Protocol

He Korowai Manaaki (Pregnancy Wraparound Care): Protocol for

a Cluster Randomized Clinical Trial

Beverley Lawton1, BSc, MBChB, Dip Obs, FRNZCGP; Francesca Storey1, BN(Hons), DTN, PGCert; Nokuthaba
Sibanda1, BSc, MSc, PhD; Matthew Bennett1, BA; Charles Lambert1, DipBA; Stacie Geller2, BA, MPA, PhD, PDF;
Liza Edmonds3, BS, MBChB, DipO&G, DCH, MMed, FRACP; Fiona Cram4, BA, PGDipPsych, PhD
1
Centre for Women's Health Research, Victoria University of Wellington, Wellington, New Zealand
2
Center for Research on Women & Gender, Center of Excellence in Women's Health, Department of Obstetrics and Gynaecology, University of Illinois,
Chicago, IL, United States
3
Women’s & Children’s Health, University of Otago, Dunedin, New Zealand
4
Katoa Ltd, Auckland, New Zealand

Corresponding Author:
Beverley Lawton, BSc, MBChB, Dip Obs, FRNZCGP
Centre for Women's Health Research
Victoria University of Wellington
44 Kelburn Parade
Wellington, 6140
New Zealand
Phone: 64 021463762
Email: bev.lawton@vuw.ac.nz

Abstract
Background: Maternal and infant health inequities between Māori (the Indigenous peoples of Aotearoa New Zealand) and
New Zealand European women are well documented and cannot be explained solely by socioeconomic status. A research center-iwi
(tribal group) partnership aims to address these disparities and improve maternal and infant health outcomes by implementing
an augmented maternity care pathway (He Korowai Manaaki) to improve access to services and evidence-informed care.
Objective: The objective of this study is to test whether an augmented maternity care pathway improves Māori infant health
outcomes.
Methods: This is a Kaupapa Māori (by, with, and for Māori) cluster randomized clinical trial involving 8 primary care practices
allocated to either an intervention arm or control arm. The intervention arm comprises an augmented maternity care pathway (He
Korowai Manaaki) offering clinical care through additional paid health care appointments and improved access to social support
(eg, housing, transport). The control arm is usual care. The primary outcome is increased timely vaccination for Māori infants,
defined as all age-appropriate vaccinations completed by 6 months of age.
Results: Recruitment commenced in November 2018 and was completed in June 2020, with 251 enrolled women recruited in
intervention primary care practices before 20 weeks of pregnancy. Publication of results is anticipated in late 2023.
Conclusions: The results will inform primary health care policy including whether the provision of augmented maternal care
pathways reduces disparities in the structural determinants of health. If effective, He Korowai Manaaki will strengthen the health
and well-being of pregnant Māori women and their babies and improve their health outcomes, laying a strong foundation for
lifelong health and well-being.
Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001155189; https://tinyurl.com/yypbef8q
International Registered Report Identifier (IRRID): DERR1-10.2196/18154

(JMIR Res Protoc 2021;10(1):e18154) doi: 10.2196/18154

KEYWORDS
maternity; inequity; Indigenous health; Māori; pregnancy; Kaupapa Māori; socioeconomic; primary health care; methodology

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(planning for the future health and well-being of the people),

Introduction and Mahia nga māhi o Kahukura (imagining and creating a
Background better future). These guiding principles provide foundations for
the research partnership [7] and the resulting He Korowai
Protecting the health and well-being of expectant mothers and Manaaki pathway (ACTRN12619001155189).
their families helps ensure that they and their baby/ies are well
cared for and supported to have good maternal outcomes. In Grounded in a Kaupapa Māori (by, with, and for Māori) inquiry
Aotearoa New Zealand, Indigenous Māori women have higher paradigm, this research prioritizes Māori ways of knowing and
rates of adverse pregnancy outcomes compared to non-Māori being, promotes a structural analysis of inequality [8], and aims
women. Māori infants have an infant death rate of 5.9 per 1000 to benefit Māori through the reduction of disparities [8-10]. The
births compared to 3.2 per 1000 births among non-Māori [1]. research practices reflect tikanga Māori (Māori customs),
Māori pregnant women and children also experience substantial including the importance of place, relationships, and Māori
socioeconomic disadvantages. Even so, the health inequities self-determination [8,9].
between Māori and New Zealand European women and infants Aims
are well documented and cannot be explained solely by
socioeconomic status [2]. Reducing these health and This study aims to implement an augmented maternity care
socioeconomic disparities is an urgent priority. pathway (He Korowai Manaaki) to improve Māori maternal
and child health outcomes and to improve access to services
At the invitation of the iwi (tribal group), He Korowai Manaaki (health, education, Well Child Tamariki Ora [WCTO], oral
(a protective cloak) was designed to surround pregnant woman health, contraception, general practice) for pregnant Māori
and their children with the best evidence-informed, timely care women and their infants.
and the best environment. As an augmented maternal care
pathway, He Korowai Manaaki was designed to improve health We hypothesize that the He Korowai Manaaki pathway, with
and well-being through pregnancy and baby’s first 2 years of early, evidence-informed care and ongoing wraparound support
life and beyond. opportunities, will improve the health outcomes of Māori
infants. If successful, this pathway will serve as a prototype for
Aotearoa New Zealand’s unique midwifery-led model of an augmented national maternity care pathway.
maternity care, established nearly 30 years ago, was purported
to hold the potential to improve health outcomes for Māori [3]; Methods
however, Māori women and whānau (family) continue to
experience persistent health inequities that impact well-being Design
throughout the maternity continuum [4]. Underrepresentation This study is a cluster randomized clinical trial with 2 study
of Māori midwives at all levels of the profession is indicative arms for pregnant women enrolled with primary care practices
of a colonized infrastructure with Māori childbirth knowledge (PCPs). Practices are the unit of randomization. Intervention
treated with skepticism [4]. PCPs utilize the He Korowai Manaaki pathway for the pregnant
Most women begin their pregnancy journey with their primary women in their practice. Control PCPs continue usual care. For
health care provider; however, the current model does not easily collection of data, all women in the intervention are individually
support continued primary health care practice involvement consented, in contrast to the control arm where deidentified data
during pregnancy nor postpartum. Transitioning to a lead is collected without individual consent.
maternity carer (LMC; typically a midwife) can lead to
Research Approval
fragmented, siloed care, inhibiting a seamless pregnancy
pathway [2] and potentially contributing to health disparities Research ethics approval was granted by the Health and
for Māori women and babies [5]. Disability Ethics Committee of New Zealand (17/STH/136) in
August 2017.
Therefore, changes in the structure of the maternity health
system are required, as improved coordination between Study Sites
midwives and general practitioners could be of great benefit for All 15 PCPs in the urban Hawkes Bay region of Aotearoa New
both equity of outcomes and efficiency of health service delivery Zealand were approached; 8 provided informed written consent
[6]. to participate in the cluster randomized clinical trial and were
randomized: 4 to intervention and 4 to control. All pregnant
Iwi Partnership
women enrolled as a patient of an intervention PCP are eligible
The research center Te Tātai Hauora O Hine (The Centre for for the intervention.
Women’s Health Research, Victoria University of Wellington)
was invited to partner with iwi/tribal group Ngāti Pāhauwera Sample Size
and develop a wraparound approach to maternity care. The aim A total of 8 practices and 216 Maori participants (4 practices
of this approach was the provision of a seamless maternal and and 108 Maori participants in each group) will provide 80%
infant care pathway with improved access to both clinical and power at a two-sided α of .05 to detect an 18.5% difference in
social support [7]. the proportion of infants who receive all age-appropriate
vaccinations by 6 months of age between the groups. For these
The guiding principles of the Ngāti Pāhauwera strategic plan
figures, we have assumed an average cluster size of 27,
are Pakatō i te ata, Pakatō i te ahiahi, Māuri mahi Māuri ora

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intracluster correlation coefficient of 0.01, and that 83.5% of Health Outcomes [15]. As a practice service change, He
the infants will receive all age-appropriate vaccinations by 6 Korowai Manaaki is facilitated through primary care–held
months of age in the intervention group and 65% in the control appointments including an extended first visit (First Touch), a
group. Our total sample size requires 432 pregnancies (216 follow-up visit, a third trimester visit, and a 6-week postnatal
control, 216 intervention). whānau (family) visit. Usual lead maternity care continues
throughout.
Based on the expected recruitment rate and pregnant women
meeting the entry criteria for the core intervention (ie, seen in General practitioners, nurse practitioners, and practice nurses
a PCP before 20 weeks of pregnancy), He Korowai Manaaki is at intervention PCPs were asked to attend an introductory
offered through intervention practices to all pregnant women training session on He Korowai Manaaki to enable the practice
for approximately 18 months from the commencement of the service change. The in-practice session provided by the
study to obtain the required sample size. researchers included education refreshers of evidence-based
antenatal care, postnatal care, and contraception as well as
Randomization information on the 4 study-funded appointments and utilization
Practices are the unit of randomization. Each of the 8 PCPs was of the pregnancy wraparound care computerized advanced form
randomly allocated to either the intervention arm (He Korowai installed into their practice management system. Education
Manaaki) or the control arm (usual care) of the trial. Covariate refresher sessions are provided by the researchers and associated
constrained randomization [11,12] was used to minimize experts over the course of the trial.
potential imbalance between intervention and control arms in
the size of the Māori population aged less than 1 year. Clinicians in intervention PCPs work from the computerized
Information on enrollment size and numbers of Māori patients advanced form to support care, screening, and navigation to
aged less than 1 year was collected for each of the 8 participating allied services. This includes referrals to specialist care and
PCPs. All possible allocations of these PCPs to the 2 trial arms services meeting the needs of wraparound care (eg, housing
were then enumerated using an algorithm blinded to the practice program, social work services, driving licensing programs, and
names. The list of allocations was then narrowed down to the dental practices).
ones that gave approximate balance in the numbers of Māori Intervention practices are also supported to provide
aged less than 1 year across the 2 arms, with each arm having contraception of the woman’s choice, free of charge (see third
4 clusters (PCPs). Finally, the actual allocation was chosen trimester appointment and 6-week postnatal appointment in
randomly from this constrained list, thereby achieving an Textbox 1) and support with transport to pregnancy-related
acceptable allocation while retaining randomness in the selection appointments (see First Touch appointment in Textbox 1).
process. No practices dropped out of the study.
Posters and published material on display at each intervention
Control Arm (Usual Care) practice inform the enrolled population of the He Korowai
Women enrolled in control practices who are pregnant during Manaaki practice change taking place for the duration of the
the study period receive usual care and will be included as research project. All women identifying as pregnant in a primary
controls in the trial. In Aotearoa New Zealand, usual care means care appointment are informed that their practice is offering an
that a woman chooses their LMC, and for most women, their augmented pathway of care for pregnant women as part of the
LMC is an independent or self-employed midwife [13]. A high research project.
proportion of the control cohort is likely to have engaged with Information about the project is also shared with individual
primary care early in pregnancy but continued primary health women by the general practitioner, nurse practitioner, or practice
care involvement during pregnancy and postpartum is unlikely. nurse. Each woman is asked to provide informed written consent
Usual care for the control cohort is expected to be predominantly for their deidentified outcome data (pregnancy and infant health
midwifery-led pregnancy care. information) to be shared with the research group in the future.
Intervention Arm (He Korowai Manaaki) The augmented pathway visits (Textbox 1) are explained, with
the First Touch appointment then being offered to all women
The He Korowai Manaaki intervention addresses both clinical
(with no data being shared for nonconsenting women). All
care (pregnancy, postpartum, neonatal, and reproductive health)
women are then invited to attend the other study appointments
and the structural determinants of health (eg, housing, transport)
(free of charge), and a recall for the next appointment is set.
with a best-practice pathway. He Korowai Manaaki includes
responses to recommendations from the New Zealand Perinatal There are no exclusions. The augmented pathway of care is
and Maternal Mortality Committee [14] and is in line with available at any stage of pregnancy, for all pregnancies (low-risk
recommendations to address structural determinants of health and high-risk).
by the Select Health Committee Inquiry into Improving Child

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Textbox 1. He Korowai Manaaki appointment descriptions.

First Touch appointment - an extended first antenatal appointment that includes:

• Time taken to respond fully to concern and queries

• Offer of screening for congenital abnormalities, sexually transmitted infections, family violence, and maternal mental health, with referrals as
warranted

• Diagnosis of any underlying medical conditions, with referral to secondary care as appropriate

• Identification of risks (maternal age, obesity, maternal mental health problems, multiple pregnancy, socioeconomic deprivation, maternal medical
conditions, previous preterm deliveries) with referral to secondary care as appropriate

• Navigation to lead maternity carer (LMC)

• Offer of prescribed pregnancy medications (folic acid, iodine)

• Whānau (family) checklist to assess whether support is required for transport to appointments, safe housing, finance, and oral health with
connection offered to existing services and support

Follow-up appointment, including:

• Follow-up of tests that have been ordered, making sure all appropriate referrals have been made

• Ensure enrollment with LMC

• Administration of maternal vaccinations, when appropriate

Third trimester appointment (open to woman’s midwife or whānau [family] to attend), including:

• Maternal vaccinations and planning for infant(s), including the provision of best-practice information about maternity health, child health

• Conversation about and planning for postnatal contraception

6-week postnatal appointment (open to woman’s midwife or whānau [family] to attend), including:

• Addressing any concerns and answer queries

• Provision of free contraceptive

• Screening for infections, family violence, and maternal mental health, with referrals as appropriate

• Education around nutrition, smoking, alcohol use, and drug use

• Education around pelvic health, navigation to women’s physio service as appropriate

• Navigation to oral health care services

• Navigation to support services such as Family Start, Well Child/Tamariki Ora, and Early Childhood Education services

Secondary Outcome Measures

Primary Outcome Measures
Secondary outcomes include infant hospitalizations and length
The primary outcome is the increase in timely vaccinations for
of stay until 1 year of age as well as obstetric, delivery, and
Māori infants. Timely vaccination is defined as all
infant outcomes plus service engagement outcomes
age-appropriate vaccinations completed by 6 months of age.
(contraception, oral health, WCTO, Early Childhood Education
[ECE]; see Table 1).

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Table 1. Outcome variables and data sources.

Data source Data source description Examples of outcome variables

ELIa The Ministry of Education information system for Early Childhood Infant registration with ECE/Te Kōhanga Reo at 2 years of ageb
Education (ECE) collects information on participating children's
enrollment and attendance.

MATc The MAT provides statistical, demographic, and clinical informa- Maternal ethnicity; smoking status at time of booking with a ma-
tion about selected publicly funded maternity services up to 9 ternity care provider and at 2 weeks postdeliveryb; hospitalization
months before and 3 months after a birth. It also contains inpatient
episodesb; antenatal screeningb; plurality; parity; mode of deliveryb;
and day-patient health event data on pregnancy, birth, and the
postnatal period for mother and baby, sourced from the National Apgar scoresb; birthweight; gestational age at deliveryb; infant
Minimum Dataset (administered by the MOHd). hospitalization in first year of lifeb; breastfeeding status at infant
dischargeb, 2 weeksb, and 6 weeks
MOH The MOH receives data from different parts of the health sector Infant registration to oral health services at 2 years of ageb
through the utilization of health services or mandatory reporting
national collections and also from national population health sur-
veys.

MORTe The MORT classifies the underlying cause of death for all deaths Infant mortalityb, ethnicity, date of death, gestational age at death,
registered in New Zealand and all registerable stillbirths using the birthweight, diagnostic codes on cause of death, sudden and unex-
World Health Organization Rules and Guidelines for Mortality pected death indicator
Coding.

NIRf The NIR is a computerized information system that has been de- Infant vaccination at 6 weeksg, 3 monthsg, 5 monthsg, and 15
veloped to hold immunization details of New Zealand children
monthsb
(administered by the MOH).

NHIh The NHI is a system used by public hospitals and other health and NHI number, area deprivation, ethnicity (maternal and infant)
disability support services to assign an alphanumeric identifier (the
NHI number) to people who use their services.

NMDSi The NMDS is a national collection of public and private hospital Ethnicity; diagnostic codes (ICD-10j)b; maternal, antenatal, or
discharge information, including coded clinical data for inpatients
postnatal hospital admissions (public)b; discharge dates and length
and day patients (hospital events).
of stay; infant hospital admissions (public)b; discharge dates and
length of stay

PHOk The PHO provides a national enrollment collection that holds pa- Infant engagement with general practitioner <8 weeks postdelivery
tient enrollment data. or after infant discharge from hospitalb

WCTOl The WCTO program is a series of health assessments and support Attendance at scheduled WCTO infant appointments at 8-10
services for children and their families from birth to 5 years and weeksb, 3-4 monthsb, 5-7 monthsb, 9-12 monthsb, and 15-18
is a gateway for parents to access primary and specialist health
monthsb; breastfeeding status at 3 months and 6 monthsb
care, education, and social services. WCTO providers submit ser-
vice coverage and data to the MOH.

a
ELI: Early Learning Information System – Ministry of Education.
b
Secondary outcome.
c
MAT: National Maternity Collection.
d
MOH: Ministry of Health.
e
MORT: Mortality Collection.
f
NIR: National Immunisation Register.
g
Primary outcome.
h
NHI: National Health Index.
i
NMDS: National Minimum Dataset.
j
ICD-10: International Classification of Diseases, Tenth Revision.
k
PHO: Primary Health Organisation.
l
WCTO: Well Child/Tamariki Ora.

reported by each health board to the MOH and is collated into

Data Collection national datasets with operational responsibility by the Client
The data for our study are generated from national and local Insights and Analytics group. Outcome data will be collected
information collections, as described by Filoche et al [16]. In using Aotearoa New Zealand’s unique patient National Health
Aotearoa New Zealand, the Ministry of Health (MOH) is Index (NHI) number to source clinical and demographic data
responsible for the oversight and funding of the country’s 20 from multiple national datasets (Table 1).
district health boards. Select clinical information is routinely

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At study end, intervention practices will send the NHIs of and the associated linked infant(s) following the relevant
women who have provided consent for their deidentified designated time period (Figure 1), the MOH will match the
outcome data to be collected and analyzed (linked to the NHI NHIs provided by the control practices to national datasets
of an infant) to the MOH. The MOH will also receive from each containing maternity, pregnancy, and delivery information (eg,
control practice the NHIs of women registered with them during the National Maternity Collection and the National Minimum
the study’s recruitment period. To identify the control group Dataset).
(women enrolled with PCPs, pregnant during the study period)
Figure 1. He Korowai Manaaki (HKM) timeline. MOH: Ministry of Health; NHI: National Health Index.

practice registrations), and (9) access to ECE (ECE

Study Variables registrations).
Primary and secondary outcomes will be tracked by patient NHI
without names. The NHIs will be matched to multiple national Analysis
databases (Table 1) up until the infant is 2 years of age to source Data analysis will occur as soon as outcome data are available
clinical and demographic data to provide a combined data source for the intervention and control arms. Within a Kaupapa Māori
for (1) sociodemographic information (ethnicity, New Zealand inquiry paradigm [8-10], the primary analysis is for Māori, with
Index of Deprivation [socioeconomic status], maternal age), (2) secondary analysis for non-Māori [17]. An intention-to-treat
clinical information (parity, plurality, LMC, gestational age at analysis will be undertaken [18] using individual participant
booking), (3) obstetric outcomes (gestation at delivery, cesarean data. All pregnancies will be analyzed (regardless of the number
section, Apgars, mortality, and morbidity), (4) antenatal of He Korowai Manaaki appointments attended), with the
screening (LMC registrations), (5) smoking status (maternal primary cohort being women seen in a PCP before 20 weeks of
smoking status at booking and after delivery), (6) vaccination pregnancy.
status (timely access to age-appropriate immunizations), (7)
The rate of infant hospitalizations will be analyzed using Poisson
infant hospitalizations (cause of mortality, intraventricular
regression, and if there is evidence of overdispersion or
hemorrhage [bleed in brain], oxygen required on discharge, and
underdispersion, then negative binomial model will be used. A
length of stay in neonatal intensive care unit), (8) access to child
generalized linear mixed model with a logit link will be used
health services (number of oral health or WCTO visits, general
to analyze binary outcomes, and a linear mixed model will be

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used to analyze continuous outcomes. All regression models of life [19]. Quality antenatal care is especially important as
will adjust for potential personal and care-related confounders part of a continuum of health care for mothers and as the starting
and for the effect of clustering within practices. Sensitivity point for the child’s developmental trajectory [20]. Māori
analyses will be undertaken for the primary outcome to women have a higher prevalence of maternal risk factors
determine the impact of missing data, and per protocol analyses compared to other women and have greater maternity needs
will be conducted. The consistency of effects for prespecified [21]; yet, their access to maternal health care and social support
subgroups will be assessed using tests for heterogeneity. does not reflect this. As primary maternity care is considered
to be a key enabler of health and well-being, it is pivotal that
Descriptions of rates, rate ratios, odds ratios, and respective
we find structural solutions that support hapū ora [19].
95% confidence intervals will be reported. Results will be
aggregated, and no individual practice will be identifiable. This augmented pathway enabled through primary care aims to
achieve equitable outcomes by meeting the structural
Results determinants and health needs of pregnant Māori women. If
successful, the findings of this trial will inform policy makers
This cluster randomized clinical trial is underway with 8 PCPs. and service providers to bring about system changes.
Practices have been randomized to either the intervention arm
or control arm. Recruitment of women ended in June 2020, with Limitations
293 women enrolled in the intervention arm, of which 251 The study limitations include whether PCPs find He Korowai
women (the primary cohort) were seen in a PCP before 20 weeks Manaaki useful in their practice. Given the heterogeneous
of pregnancy. Data collection will commence in early 2022 and make-up of PCPs, the benefits for each practice may vary
be complete by mid-2023, and the analysis results are anticipated depending on their population, resources, and needs. The study
to be published in late 2023. The explicit and conscious decision does not measure which component(s) of the pathway are taken
to use an indigenous lens when analyzing the data allows up; however, an intention-to-treat analysis is widely accepted
outcomes to be viewed with a focus on advantage and privilege as the gold standard for assessing the superiority of the
rather than one of disparity. intervention in randomized trials [18].
Further, this study will be carried out in an urban area with a
Discussion high Māori population, and the results may not be generalizable
Quality, culturally responsive maternal care is expected and to other areas and other communities.
essential to the achievement of Māori pregnancy, birthing, and Conclusions
motherhood aspirations of “hapū ora” [19], that is, the health
The results of this study will inform policy and clinical pathways
and well-being of Māori mothers-to-be and their babies.
for Māori and be valuable in informing agencies about the
Pregnancy is an important period during which health and
potential health and well-being gains from an iwi-initiated
support services can provide information, care, and resources
augmented national maternity care pathway accessible through
to enable the optimal environment for fetal and neonatal stages
primary care.

Acknowledgments
This study is funded by Te Kanuihera Rangahau Hauora O Aotearoa (The Health Research Council of New Zealand). BL, senior
author and principal investigator, conceived the study and has overall responsibility for the study. MB, CL, BL, and FC guide
the project. FS drafted the manuscript. NS provided statistical input and guided the methodology. All authors contributed to the
study design and manuscript writing and approved the final manuscript.

Conflicts of Interest
None declared.

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Abbreviations
ECE: Early Childhood Education
LMC: lead maternity carer
MOH: Ministry of Health
NHI: National Health Index
PCP: primary care practice
WCTO: Well Child Tamariki Ora

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 JMIR RESEARCH PROTOCOLS Lawton et al

Edited by G Eysenbach; submitted 09.02.20; peer-reviewed by S Kildea, F Goodyear-Smith; comments to author 12.06.20; revised
version received 01.10.20; accepted 15.12.20; published 29.01.21
Please cite as:
Lawton B, Storey F, Sibanda N, Bennett M, Lambert C, Geller S, Edmonds L, Cram F
He Korowai Manaaki (Pregnancy Wraparound Care): Protocol for a Cluster Randomized Clinical Trial
JMIR Res Protoc 2021;10(1):e18154
URL: http://www.researchprotocols.org/2021/1/e18154/
doi: 10.2196/18154
PMID: 33512321

©Beverley Lawton, Francesca Storey, Nokuthaba Sibanda, Matthew Bennett, Charles Lambert, Stacie Geller, Liza Edmonds,
Fiona Cram. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.01.2021. This is an
open-access article distributed under the terms of the Creative Commons Attribution License
(https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information,
a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be
included.

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