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Perinatal outcomes of planned place of birth in a Dutch birth centre compared to alternative planned places of birth Results of the Dutch Birth Centre Study

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Manuscript ID Article Type:

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BMJ Open bmjopen-2017-016958 Research 27-Mar-2017

Primary Subject Heading:

Keywords:

Evidence based practice

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Secondary Subject Heading:

Obstetrics and gynaecology

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Hermus, Marieke; TNO, Child Health; Leids Universitair Medisch Centrum, Obstetrics Hitzert, Marit; Erasmus MC, Boesveld, Inge; Jan van Es Instituut van den Akker-van Marle, Elske; Leiden University Medical Centre, Department of Medical Decision Making van Dommelen, Paula; Netherlands Institute of Applied Sciences TNO, statistics Franx, Arie; University Medical Center Utrecht, Obstetrics and gynecology de Graaf, J; Erasmus MC university Medical Centre Rotterdam, Department of Obstetrics and Gynaecology van Lith, Jan; LUMC, Obstetrics Luurssen-Masurel, Nathalie; TNO, Child Health Steegers, Eric; Erasmus MC, Obstetrics and Gynaecology Wiegers, Trees; Nederlands Instituut voor Onderzoek van de Gezondheidszorg van der Pal-de Bruin, Karin; TNO, Child Health

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midwifery, midwife-led units, delivery rooms, outcome assessment (Health care), the Netherlands, birthing centres

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1

Perinatal outcomes of planned place of birth in a

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Dutch birth centre compared to alternative

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planned places of birth

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Results of the Dutch Birth Centre Study

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Marieke AA Hermus, PhD student and community midwife 1,2,3 Marit Hitzert, PhD student 4, Inge C Boesveld, PhD student 5, Elske van den Akker-van Marle, health economist 6, Paula van Dommelen, senior statistician 7, Arie Franx, professor in obstetrics 8, Johanna P de Graaf, senior researcher 4, Jan MM van Lith, professor in obstetrics 2 , Nathalie Luurssen-Masurel, junior researcher 1 , Eric AP Steegers, professor in obstetrics 4, Therese A Wiegers, senior researcher 9 ,Karin M Van der Pal-de Bruin, epidemiologist1

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1Department

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2Department of Obstetrics, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, the Netherlands

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3Midwifery

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4Department

of Obstetrics and Gynaecology, Erasmus University Medical Centre, PO Box 2040, 3000 CA Rotterdam, the Netherlands

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5Jan

van Es Institute (Netherlands Expert Centre Integrated Primary Care), Wisselweg 1314 BG Almere, the Netherlands

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6Department

of Medical Decision Making, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, the Netherlands

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of Life Style, TNO (Netherlands Organisation for Applied Scientific Research), PO Box 2215, 2316 ZL Leiden, the Netherlands

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Division Woman and Baby, University Medical Centre Utrecht, PO box 85500, 3508 GA Utrecht, the Netherlands

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9 NIVEL (Netherlands Institute for Health Services Research), PO Box 1568, 3500 BN Utrecht, the Netherlands

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of Child Health, TNO (Netherlands Organisation for Applied Scientific Research), PO Box 2215, 2316 ZL Leiden, the Netherlands

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Practice Trivia, Werkmansbeemd 2, 4907 EW Oosterhout, the Netherlands

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Correspondence to: Marieke Hermus, Wijde Omloop 32, 4904 PP, Oosterhout, the Netherlands, +31(6)48253145, [email protected]

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Word count: 5453

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Abstract

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Objectives To compare perinatal outcomes of planned birth in a birth centre to planned

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hospital and planned home birth for low risk term women who start labour under

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responsibility of a community midwife in the Netherlands.

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Design Prospective cohort study.

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Setting Low risk women under care of a community midwife and living in a region with

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one of the 21 participating Dutch birth centres or in a region with the possibility for

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midwife-led hospital birth. Home birth was possible in all regions included in the study.

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Participants 3455 eligible low risk term (≥ 37 weeks gestation) women (1686

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nulliparous and 1769 multiparous) who gave birth between July 2013 and December

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2013: 1668 planned birth centre births, 701 planned midwife-led hospital births and

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1086 planned home births.

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Main outcome measurements Two primary outcomes were assessed to compare

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perinatal outcomes by planned place of birth being a birth centre, hospital or at home: 1)

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the Optimality Index-NL2015: a tool to measure ‘maximum outcome with minimal

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intervention’; and 2) a composite adverse outcome score.

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Results There was no difference in Optimality Index-NL2015 for women who planned

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to give birth in a birth centre compared to women who planned to give birth in a

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hospital. Although effect sizes were small, women who planned to give birth at home

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had a higher optimality index than women who planned birth in a birth centre, the

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difference being larger for multiparous than for nulliparous women. No differences were

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found in the composite adverse outcome score for the different planned places of birth.

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Conclusion Perinatal outcomes of women with planned birth centre births were

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comparable with planned midwife-led hospital births. Women with planned home births

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had better perinatal outcomes.

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ARTICLE SUMMARY

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Strengths and limitations

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The strengths of the study are the participation of all eligible Dutch birth centres,

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the high participation rate of midwifery practices and the use of the Optimality

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Index NL.

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Netherlands.

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This is the first study to evaluate the effect of birth centre care in the

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The Optimality Index (main outcome measurement tool) focuses on optimality

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for processes and outcomes, instead of on adverse outcomes, which are rare in a

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population of low risk women, who are at the onset of labour under care of a

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community midwife. •

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The power of this study is too low to find a difference in adverse outcomes.

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Besides that the Optimality Index highlights a sum score of optimal events, it reflects the effect of interventions on the whole level of childbirth.

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INTRODUCTION

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In the Netherlands low risk pregnant women who start labour at or after 37 weeks

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gestation and under care of a community midwife can choose whether they want to give

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birth at home, in a hospital or in a birth centre. The community midwife guides them

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besides natal care also during pregnancy and the postnatal period. Most midwives work

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in group practices in their own premises and they are autonomous in their actions and

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decisions [1]. When a complication occurs or medical assistance for pharmacologic pain

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relief is requested, the woman will be referred to the obstetric unit in a hospital.

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Depending on the reason for referral, either the obstetrician or the neonatologist then

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takes over responsibility of care from the community midwife. Reasons for referral are

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written in the so called List of Obstetric Indications. This is a multidisciplinary guideline

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in which all professionals involved in maternity care reached general agreement on the

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indications for consultation and referral [2].

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In the last decade fewer women planned to give birth at home. In 2004 around 48% of

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all low risk births in the Netherlands were planned at home; in 2014 this number

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decreased to 24%. For low risk women who plan to give birth out of home there are two

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options: a birth centre or a hospital [3]. Birth centres are a new development in most

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Dutch regions and the number of birth centres increased in recent years [4] [Hermus et

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al, 2016a] . Recently a definition of a Dutch birth centre was developed: “A birth centre is

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a midwifery-managed location that offers care to low risk women during labour and

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birth. They have a homelike environment and provide facilities to support physiological

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birth. Community midwives take primary professional responsibility for care. In case of

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referral the obstetric caregiver takes over the professional responsibility of care“ [5]

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[Hermus et al, 2016a]. Different types of birth centres can be distinguished based on

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location and integration profile [7][Hermus et al, 2016a].The other option for low risk

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women is to give birth in a conventional labour setting in a hospital room under care of a

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community midwife (midwife-led hospital birth). These rooms are often located on the

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obstetric unit. Although the community midwife is the one responsible for the care

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during labour and birth, this room is managed by obstetricians and the community

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midwife does not participate in the organization and preferred facilities. Although a

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woman is free to choose her preferred planned place of birth, not all birth locations are

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available within her close neighbourhood: some women have a birth centre in their

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neighbourhood, some a hospital and some both.

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No research on the perinatal outcomes of planned birth centre births was performed in

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the Netherlands before. Studies on birth centre care in other countries have shown that

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low risk women who planned birth in a birth centre experienced significantly fewer

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interventions compared to women who planned birth in a conventional labour setting in

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a hospital. This included fewer intra partum caesarean sections and less frequent use of

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obstetric analgesia and augmentation of labour [6-10]. Earlier research on the effect of

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planned place of birth in the Netherlands focused on the evaluation of the conventional

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labour setting in a hospital and home [11,12].

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In 2013 a nationwide study, the Dutch Birth Centre Study (DBC study), started to

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evaluate birth centre care by investigating perinatal outcomes, experiences of clients

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and caregivers and economic outcomes [5]. Aim of the present study, part of the DBC

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study, is to assess the perinatal outcomes of a planned birth in a birth centre compared

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to planned birth in a hospital or at home for low risk term women who start labour

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under care of a community midwife. The outcomes of a planned birth in different types

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of birth centres based on location and integration profile were studied as well.

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METHODS

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A prospective cohort study was designed to compare perinatal outcome of planned birth

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in a birth centre compared to planned midwife-led hospital birth or planned home birth.

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Design and planning of the study were presented to the Medical Ethics Committee of the

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University Medical Centre Utrecht. They confirmed that this study agrees with Dutch

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legal regulations for the methods used and because of that further formal ethical

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approval of this study is not required [13].

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Setting and participants

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Within the study period July 2013 to December 2013 community midwives were asked

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to record data for each birth that started under their care regardless of the planned

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place of birth. In September 2013 there were 23 birth centres in the Netherlands

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according to the definition above [Hermus et al, 2016a]. Condition for participation in

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this study was that the birth centre in that region was in service for more than a half

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year before the start of the study period, leading to exclusion of two birth centres. A

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minimum of 3 midwifery practices working in the area of each birth centre in the

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Netherlands were randomly recruited to collect data for a minimum period of three

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months. Midwifery practices in areas where there was the possibility for midwifery led

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hospital birth were recruited to collect data of planned midwife-led hospital births.

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Planned birth at home was an option for women in all participating midwifery practices.

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In total data were obtained by 110 midwifery practices . In our study participated 21

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birth centres and 46 hospital locations where midwife-led birth was possible.

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Birth centres were distinguished based on their location in relation to the obstetric unit

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and based on their level of integration. Based on location the 3 types were:1)

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freestanding (not on hospital grounds), 2) alongside (separate from an obstetric unit but

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in a hospital or on hospital grounds) or 3) on-site (within an obstetric unit of a hospital).

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In September 2013 3 freestanding, 14 alongside and 6 on-site birth centres existed in

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the Netherlands [Hermus et al, 2016a]. All birth centres except 1 alongside and 1 on-site

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met the inclusion criteria and participated in this research.

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Birth centres were also classified into 3 groups with distinctive integration profiles:1)

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mono-disciplinary-oriented birth centres (MOBC). MOBCs are more focused on being a

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facility to give birth than on improving collaboration between care providers or

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realizing integration of care. 2) Multi-disciplinary-oriented birth centres (MUBC). MUBCs

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can be regarded as facilities to give birth with a focus on integrated birth care. 3) Birth

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centres with a mixed profile (MIBC). MIBCs are a mixed group. They are less

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homogeneous in their organization than the birth centres in the other two groups. In

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September 2013 10 MOBCs, 6 MUBCs and a remaining group of 7 MIBCs existed in the

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Netherlands [Boesveld et al, 2016]. All birth centres except 1 MOBC and 1 MUBC met the

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inclusion criteria and participated in this research.

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Data collection

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In the Netherlands individual baseline and perinatal outcome data are electronically

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collected in one national database: The Netherlands Perinatal Registry (Perined) [14].

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To collect additional and more detailed data about process indicators and outcomes a

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case report form (CRF) was developed for this study [5]. For each women, the obtained

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data of the CRF were linked to data from the Netherlands Perinatal Registry by means of

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unique anonymous identifiers for the client and midwifery practice. If linkage was not

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established because of lacking data in Netherlands Perinatal Registry the missing

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information was manually obtained from the client record in the midwifery practice and

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linked. Cases where linkage between data from CRF and data from the Netherlands

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Perinatal Registry was not established were excluded.

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Data were collected for all term (>= 37 weeks gestational age) women at the start of

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labour under care of a community midwife. Excluded were woman with a medium-risk

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situation (D-indications according to the List of Obstetric Indications), i.e. an obstetric

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history of heamorraghia postpartum or manual placenta removal [2]. Also women with

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no specific choice for planned place of birth at the onset of labour were excluded.

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Two main outcome measures were used: the Optimality Index (OI-NL2015) and a

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composite adverse outcome score (CAO). The Optimality Index was used because

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serious adverse outcomes are relatively uncommon in term women under care of a

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community midwife. The OI-NL2015 is a tool to measure ‘maximum outcome with

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minimal intervention’. It is designed to yield a summary score reflective of processes of

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care and clinical outcomes in relation to background risk [15-17]. The OI-NL2015 has 31

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items distributed over 3 clinical domains: intrapartum, neonatal and postpartum; each

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item meeting the criteria for optimality is scored “1”. It includes conditions (e.g.

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preeclampsia) and interventions (e.g., amniotomy, episiotomy, referral and epidural

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anaesthesia) [Hermus et al, 2016b].

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A composite adverse outcome score (CAO) of adverse maternal and neonatal outcomes

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was used to assess the effect of a planned birth in a birth centre compared to alternative

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settings on adverse outcomes. The CAO is a percentage based on the presence of at least

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one of the following adverse outcomes: maternal mortality within 42 days after birth,

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(sub) total rupture, blood loss of more than one litre, perinatal mortality within 7 days

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after birth, Apgar score below 7 at 5 minutes after birth, admission to the neonatal

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intensive care unit within 48 hours after birth.

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The presence of all individual items of the composite adverse outcome score except one

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are part of the Optimality Index-NL 2015; Apgar Score < 7 after 5 minutes was not

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included in the items of the Optimality Index-NL 2015 as the criterion for optimal for

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‘Apgar score at 5 minutes was >= 9’. Processes and outcomes were considered as not

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happened if there was no registration of them found in the Netherlands Perinatal

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Registry.

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Data analysis

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To determine whether there was a difference in outcomes between subgroups the sum

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scores of the 31 items of the OI-NL2015 and the CAO percentages were analysed. The

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outcomes were adjusted for background variables (maternal age (mean), social

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economic status (SES) (high/medium/low), urbanization (= 9 after 5 minutes’ was less likely in MUBCs (91.8%) compared

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to MOBCs (95.6%) for nulliparous women.

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A higher proportion of women with planned birth in a birth centre of the group of multi-

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disciplinary oriented birth centres had ‘no amniotomy’ compared to women with

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planned birth in a mono-disciplinary oriented birth centre or a birth centre from the

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mixed group (nulliparous: MUBCs 63.9%, MOBCs 50.2% MIBCs 47.5%; multiparous:

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MUBCs 53.7%, MOBCs 34.2% MIBCs 38.4%).

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[here Table 3]

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Optimality Index NL-2015

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Multiparous women had a higher mean sum score (28.3) (a more favourable outcome)

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on the OI-NL2015 than nulliparous women (26.0).

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Birth centre compared to alternative places

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Nulliparous who planned a birth centre birth had a lower mean score on the OI-

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NL2015(25.8) compared with nulliparous with planned place of birth in a hospital (26.0,

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p< 0.05). The effect size of this difference was 0.07 (non-trivial). There was no

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significant difference between multiparous women who planned birth in a birth centre

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and in a hospital. Both nulliparous and multiparous women who planned birth at a birth

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centre had lower scores on the OI-NL2015 compared to women with the same parity

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that planned birth home (nulliparous: birth centre 25.8, home 26.3; p 1500 /km²) Intermediate density areas (500 - 1500 / km²) Thinly populated areas (= 37 weeks gestational age) women at the start of labour under care of a community midwife, regardless their planned place of birth. Excluded were women with a medium-risk situation (D-indications according to the List of Obstetric Indications, i.e. an obstetric history of postpartum heamorrhage or manual removal of the placenta [2]. Also women with no specific choice for planned place of birth at the onset of labour were excluded. (see lines 218 to 238) Condition for participation in this study was that the birth centre in that region was in service for more than a half year before the start of the study period. (see lines 171 to

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Participants

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(a) Cohort study—Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up

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Variables

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Case-control study—Give the eligibility criteria, and the sources and methods of case ascertainment and control selection. Give the rationale for the choice of cases and controls Cross-sectional study—Give the eligibility criteria, and the sources and methods of selection of participants (b) Cohort study—For matched studies, give matching criteria and number of exposed and unexposed Case-control study—For matched studies, give matching criteria and the number of controls per case Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable

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Our primary main outcome measure was the Optimality Index-2015(OI-NL2015), a tool to measure ‘maximum outcome with minimal intervention’ [22]. It emphasizes that in general childbirth is a normal physiologic process with high numbers of optimal processes and outcomes rather than a pathological process of disease. The OI-NL2015 is specifically useful to measure quality of obstetric care for women with low-risk pregnancies in which cases adverse perinatal outcomes are rare [23]. The adoption of the ‘optimality concept’ avoids the problem of defining what is normal or abnormal in obstetrical care, and it shifts the focus from rare adverse events, i.e. perinatal mortality, to evidence-based optimal events. The optimality index is designed to yield a summary score reflective of processes of care and clinical outcomes in relation to the background risk [22,24,25]. The OI-NL2015 has 31 items distributed over three clinical perinatal domains: intrapartum, postpartum and neonatal; each item meeting the criteria for optimality is scored “1”. It includes conditions (e.g. preeclampsia) and interventions (e.g., amniotomy, episiotomy, referral and epidural analgesia). Its reliability is demonstrated in earlier research. [22] The OI-NL2015 is based on items that were included in the national perinatal database. The former version of the OI-NL included a perinatal background index to adjust for differences in maternal background. [23]Because almost none of these items are included in the national perinatal database the new version of the Optimality Index has to be adjusted, after calculating the sum score, for ethnicity, maternal age, social economic status and urbanization level. [22]

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Our secondary outcome measure was a description of a maternal and perinatal composite adverse outcome score (CAO). Adverse maternal and neonatal outcomes were used to assess the effect of a planned birth in a birth centre compared to alternative settings on adverse outcomes. The CAO is a percentage based on the presence of at least one of the following adverse outcomes: maternal death (within 42 days of giving birth), third or fourth degree of perineal tear , postpartum haemorrhage (>1000 ml in 24 hours, stillbirth diagnosed after presentation in labour, early neonatal death (