ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000551493

Ethics application status

Approved

Date submitted

18/10/2007

Date registered

26/10/2007

Date last updated

14/01/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Screening for pregnancy endpoints: preeclampsia, growth restricted baby and spontaneous preterm birth.

Scientific title

Screening nulliparous women to identify the combinations of clinical risk factors and/or biomarkers required to predict preeclampsia, small for gestational age babies and spontaneous preterm birth.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

SCOPE; (Also known in the in the United Kingdom as MAPS in Ireland as SCOPE Ireland).

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Preeclampsia.

Small for gestational age babies (SGA).

Spontaneous preterm birth.

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Prospective cohort, with case cohort design. The cohort comprises nulliparous women with a singleton pregnancy in New Zealand, Australia, United Kingdom and Ireland who are prospectively studied from 14 weeks gestation to postpartum. Cases are women who develop one or more of the following conditions: preeclampsia, an SGA baby or spontaneous preterm birth. For all secondary endpoints the cases will be women with the secondary endpoint of interest.
Data on all known risk factors for preeclampsia, spontaneous preterm birth and SGA are collected at 15+/-1 and 20 +/-1 weeks’ gestation by interview and examination of the women. Blood and urine specimens are obtained at both time points, with a high vaginal swab taken at the 20 week visit. Additional information is collected about diet, lifestyle, stress, depression and other mood disorders. Ultrasound data are obtained at 20 weeks on fetal measurements, anatomy, uterine and umbilical artery Doppler and cervical length. Fetal growth, uterine and umbilical Dopplers are measured at 24 weeks. Pregnancy outcome is tracked and the woman seen within 48 hours of delivery. Baby measurements are obtained within 48 hours of delivery.
Proteomic, targeted genomic and metabolomic studies are being performed to identify biomarkers, which will then be evaluated and validated as screening tests by using quantitative, high throughput methods (such as multiplex immunoassay) to measure specific analytes in the cohort. These data will then be used to develop predictive algorithms based on clinical risk factors alone, biomarkers alone or combinations of both.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

In the main cohort study, when the outcome is preeclampsia, controls are women without preeclampsia. For SGA, controls are women without SGA. For spontaneous preterm birth, controls are women without spontaneous preterm birth. A case cohort design will be used when investigating prediction based on blood biomarkers, with controls comprising women randomly selected from the non-disease groups described above.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Preeclampsia defined as gestational hypertension (systolic blood pressure (BP) >= 140 mmHg and/or diastolic BP >= 90mmHg (Korotkoff V) on at least 2 occasions 4 hours apart after 20 weeks gestation but before the onset of labour) or postpartum systolic BP >= 140 mmHg and/or diastolic BP >= 90mmHg postpartum on at least 2 occasions 4 hours apart with proteinuria >= 300 mg/24h or spot urine protein: creatinine ratio >=30 mg/mmol creatinine or urine dipstick protein >= ++ or any multi-system complication of preeclampsia.
Multisystem complications include any of the following:
1. Acute renal insufficiency defined as a new increase in serum creatinine >=100 umol/L antepartum or >130 umol/L postpartum
2. Liver disease defined as raised aspartate transaminase and/or alanine transaminase >45 IU/L and/or severe right upper quadrant or epigastric pain or liver rupture
3. Neurological problems defined as eclampsia or imminent eclampsia (severe headache with hyperreflexia and persistent visual disturbance) or cerebral haemorrhage
4. Haematological including thrombocytopenia (platelets <100 x 109/L), disseminated intravascular coagulation or haemolysis, diagnosed by features on blood film (e.g., fragmented cells, helmet cells) and reduced haptoglobin.

Timepoint [1]

At any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery.

Primary outcome [2]

SGA defined as: birthweight <10th% using customized centiles, adjusted for maternal weight, height, parity, ethnicity and infant sex.

Timepoint [2]

First 24 hours after baby's birth.

Primary outcome [3]

Spontaneous preterm birth defined as spontaneous preterm labour or preterm premature rupture of the membranes (PPROM) resulting in preterm birth at <370 weeks.

Timepoint [3]

When the mother has given birth to the baby.

Secondary outcome [1]

Early onset preeclampsia defined as preeclampsia resulting in delivery at <340 weeks.

Timepoint [1]

At any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery.

Secondary outcome [2]

Preeclampsia with severe fetal or neonatal complications defined as preeclampsia resulting in either delivery at <320 weeks or major neonatal morbidity or stillbirth or neonatal death or post-neonatal death. Preterm major neonatal morbidity is defined as one or more of the following amongst babies delivered before 37 weeks: Grade III or IV intraventricular haemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of prematurity stage 3 or 4, sepsis (blood or CSF culture proven) or cystic peri-ventricular leukomalacia. These conditions will be defined using the Australian and New Zealand neonatal network definitions. Term major neonatal morbidity is defined as one or more of the following amongst babies delivered at or after 37 weeks gestation: Grade II or III hypoxic ischemic encephalopathy, ventilation>24 hours, neonatal unit admission >4 days, Apgars <4 at 5 mins, cord arterial pH<7.0 and/or base excess >-15 or neonatal seizures.

Timepoint [2]

When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery.

Secondary outcome [3]

Preeclampsia with severe maternal complications defined as the development of preeclampsia with one or more of the following: maternal death, persistent severe hypertension (systolic blood pressure >=170 mmHg or diastolic blood pressure >=110 mmHg on more than one occasion antepartum or postpartum) or multi-system complication as defined above.

Timepoint [3]

At any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery.

Secondary outcome [4]

Preeclampsia with either severe maternal complication or severe fetal or neonatal complications includes all preeclamptic pregnancies affected by severe maternal or severe fetal or neonatal complications as defined above.

Timepoint [4]

Preeclampsia with severe maternal complications: at any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery. Preeclampsia with severe fetal or neonatal complications: When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery.

Secondary outcome [5]

Early onset SGA defined as birthweight <10th customised centile resulting in delivery at <340 weeks.

Timepoint [5]

First 24 hours after baby's birth.

Secondary outcome [6]

SGA with severe fetal or neonatal complications defined as SGA and either delivery at <320 weeks or major neonatal morbidity or stillbirth or neonatal death or post-neonatal death. Preterm major neonatal morbidity is defined as one or more of the following amongst babies delivered before 37 weeks: Grade III or IV intraventricular haemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of prematurity stage 3 or 4, sepsis (blood or CSF culture proven) or cystic peri-ventricular leukomalacia. These conditions will be defined using the Australian and New Zealand neonatal network definitions. Term major neonatal morbidity is defined as one or more of the following amongst babies delivered at or after 37 weeks gestation: Grade II or III hypoxic ischemic encephalopathy, ventilation>24 hours, neonatal unit admission >4 days, Apgars <4 at 5 mins, cord arterial pH<7.0 and/or base excess>-15 or neonatal seizures.

Timepoint [6]

When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery.

Secondary outcome [7]

Early onset spontaneous preterm birth defined as spontaneous preterm labour or PPROM resulting in delivery at <340 weeks.

Timepoint [7]

When the mother has given birth to the baby.

Secondary outcome [8]

Spontaneous preterm birth with severe fetal or neonatal complications defined as spontaneous preterm labour or PPROM resulting in either delivery at <320 weeks or spontaneous preterm birth resulting in major neonatal morbidity or stillbirth or neonatal death or post-neonatal death. Preterm major neonatal morbidity is defined as one or more of the following amongst babies delivered before 37 weeks Grade III and IV intraventricular haemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of prematurity, stage 3 or 4, sepsis (blood or CSF culture proven) or cystic peri-ventricular leukomalacia. These conditions will be defined using the Australian and New Zealand neonatal network definitions.

Timepoint [8]

When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery.

Secondary outcome [9]

9: Spontaneous preterm birth with PPROM defined as preterm birth at <370 weeks following PPROM.

Timepoint [9]

When the mother has given birth to the baby.

Secondary outcome [10]

10: Spontaneous preterm birth without PPROM defined as spontaneous preterm labour with intact membranes resulting in preterm birth at <370 weeks preterm birth.

Timepoint [10]

When the mother has given birth to the baby.

Secondary outcome [11]

Gestational Diabetes Mellitus (GDM) defined by the local criteria at each participating center.

Timepoint [11]

At any stage during pregnancy after recruitment until delivery.

Eligibility

Key inclusion criteria

Nulliparous women, with a singleton pregnancy, between 14wks 0 days and 16wks 6 days gestation who give informed consent to participate in SCOPE.

Minimum age

No limit

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion criteria: Unsure of last menstrual period (LMP) and unwilling to have ultrasound scan at <= 20 weeks, > =3 miscarriages, >=3 terminations, major fetal anomaly/abnormal karyotype, essential hypertension treated pre-pregnancy, moderate-severe hypertension at booking >=160/100 mmHg, diabetes, renal disease, systemic lupus erythematosus, anti-phospholipid syndrome, sickle cell disease, HIV positive, major uterine anomaly, cervical suture, knife cone biopsy, ruptured membranes now, long term steroids, treatment low-dose aspirin, treatment calcium (>1g/24h), treatment eicosopentanoic acid (fish oil), treatment vitamin C >=1000mg & Vit E >=400iu, treatment heparin/low molecular weight heparin.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

11/11/2004

Actual

11/11/2004

Date of last participant enrolment

Anticipated

Actual

8/02/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

7500

Accrual to date

Final

5690

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment postcode(s) [1]

5112

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Country [2]

United Kingdom

State/province [2]

Country [3]

Ireland

State/province [3]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Foundation of Research Science and Technology

Address [1]

PO Box 12-240
Wellington

Country [1]

New Zealand

Funding source category [2]

Government body

Name [2]

Health Research Council

Address [2]

PO Box 5541
Wellesley St
Auckland

Country [2]

New Zealand

Funding source category [3]

Hospital

Name [3]

Evelyn Bond Charitable Fund

Address [3]

Auckland District Health Board
PO Box 26-417
Epsom
Auckland

Country [3]

New Zealand

Funding source category [4]

Government body

Name [4]

South Australia Premier Science and Research Fund

Address [4]

GPO Box 2343
Adelaide SA 5001

Country [4]

Australia

Funding source category [5]

Charities/Societies/Foundations

Name [5]

Guys and St Thomas' Charity

Address [5]

The Counting House Guy's Hospital
1st Floor
St Thomas St
London SE1 9RT

Country [5]

United Kingdom

Funding source category [6]

Government body

Name [6]

Health Research Board Ireland

Address [6]

73 Lower Baggot St
Dublin 2

Country [6]

Ireland

Funding source category [7]

University

Name [7]

University of Manchester Proof of Concept Funding UK

Address [7]

University of Manchester
Hathersage Rd
Manchester M13 0JH

Country [7]

United Kingdom

Funding source category [8]

Government body

Name [8]

Biotechnology and Biological Sciences Research Council UK

Address [8]

Polaris House
North Star Ave
Swindon SN2 1UH

Country [8]

United Kingdom

Funding source category [9]

Government body

Name [9]

National Health Services NEAT Grant UK -Grant

Address [9]

National Institute for Health Research
Rm 132
Richmond Hse
79 Whitehall
London SW1A 2NL

Country [9]

United Kingdom

Funding source category [10]

Charities/Societies/Foundations

Name [10]

Tommy's the Baby Charity UK

Address [10]

109 High Street
Thame
Oxon OX9 3DZ

Country [10]

United Kingdom

Funding source category [11]

Charities/Societies/Foundations

Name [11]

Cerebra

Address [11]

Cerebra
2nd Floor Offices
The Lyric Bldg
King St
Carmarthen SA31 1BD

Country [11]

United Kingdom

Funding source category [12]

Government body

Name [12]

Health Research Board

Address [12]

Grattan House, 67-72 Lower Mount Street, Dublin 2, Ireland

Country [12]

Ireland

Primary sponsor type

University

Name

Associate Professor Robyn North

Address

SCOPE Study
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1172

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

Associate Professor Lesley McCowan

Address [1]

SCOPE Study
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1172

Country [1]

New Zealand

Other collaborator category [1]

University

Name [1]

Professor Gustaaf Dekker

Address [1]

Discipline of Obstetrics and Gynaecology
University of Adelaide
Lyell McEwen Hospital
Haydown Rd
Elizabeth Vale SA 5112

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Dr Claire Roberts

Address [2]

Discipline of Obstetrics and Gynaecology
University of Adelaide
SA 5005

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Professor Philip Baker

Address [3]

Maternal and Fetal Health Research Unit
University of Manchester
St Mary's Hospital
Whitworth Park M13 0JH

Country [3]

United Kingdom

Other collaborator category [4]

University

Name [4]

Professor Lucilla Poston

Address [4]

Maternal and Fatal Research Unit
Division of Reproduction and Endocrinology
King's College London
St Thomas' Hospital
London SE1 7EH

Country [4]

United Kingdom

Other collaborator category [5]

University

Name [5]

Professor Andrew Shennan

Address [5]

Maternal and Fatal Research Unit
Division of Reproduction and Endocrinology
King's College London
St Thomas' Hospital
London SE1 7EH

Country [5]

United Kingdom

Other collaborator category [6]

University

Name [6]

Professor James Walker

Address [6]

Academic Department of Obstetrics & Gynaecology
University of Leeds
L 9
Gledhow Wing
St James University Hospital
Beckett St
Leeds LS9 7TF

Country [6]

United Kingdom

Other collaborator category [7]

University

Name [7]

Mr Nigel Simpson

Address [7]

Academic Department of Obstetrics & Gynaecology
University of Leeds
L 9
Gledhow Wing
St James University Hospital
Beckett St
Leeds LS9 7TF

Country [7]

United Kingdom

Other collaborator category [8]

University

Name [8]

Dr Louise Kenny

Address [8]

Department of Obstetrics and Gynaecology
University College Cork
Cork University Maternity Hospital
Wilton
Cork

Country [8]

Ireland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

Private Bag 92 522
Wellesley St
Auckland

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

23/04/2003

Ethics approval number [1]

AKX/02/00/364

Ethics committee name [2]

Central Northern Adelaide Health Service, Ethics of Human Research Committee

Ethics committee address [2]

Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale
Adelaide SA 5112

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

02/09/2005

Ethics approval number [2]

2005082

Ethics committee name [3]

South East Multi-centre Research Ethics Committee
St Thomas Hospital Research Ethics Committee

Ethics committee address [3]

Aylesford
Kent

Ethics committee country [3]

United Kingdom

Date submitted for ethics approval [3]

Approval date [3]

19/01/2007

Ethics approval number [3]

06/MRE01/98

Ethics committee name [4]

South East Multi-centre Research Ethics Committee
Central Manchester Research Ethics Committee

Ethics committee address [4]

Aylesford
Kent

Ethics committee country [4]

United Kingdom

Date submitted for ethics approval [4]

Approval date [4]

19/01/2007

Ethics approval number [4]

06/MRE01/98

Ethics committee name [5]

Clinical Research Ethics Committee of the Cork Teaching Hospitals

Ethics committee address [5]

Secretariat, Clinical Research Ethics Committee of The Cork Teaching Hospitals
1st Floor
Lancaster Hall
6 Little Hanover Street
Cork

Ethics committee country [5]

Ireland

Date submitted for ethics approval [5]

01/09/2007

Approval date [5]

Ethics approval number [5]

Summary

Brief summary

Preeclampsia, spontaneous preterm birth and birth of a small for gestational age (growth restricted) baby are the three major complications of late pregnancy, affecting approximately 19% of first pregnancies. They are a leading cause of maternal morbidity, perinatal morbidity and mortality, neuro-developmental handicap and lifelong health consequences. There are a number of clinical risk factors and biomarkers for these diseases, but currently there are no predictive tests for these conditions. Although no single clinical risk factor or biomarker is a useful predictor, novel combinations of clinical risk factors and/or biomarkers are likely to perform as reliable screening tests for these conditions. 
The primary aim of SCOPE is to produce clinically useful screening tests based on 1) clinical risk factors, 2) biomarkers and 3) a combination of clinical risk factors and biomarkers to detect first time mothers at high risk of preeclampsia, spontaneous preterm birth and/or small for gestational age babies. 
If successful, this will allow individualised tailoring of antenatal care for future first time mothers and where appropriate, intervention to prevent these conditions. This will empower women and their clinicians to make informed decisions about their care in pregnancy, thereby optimizing the health of mothers and babies.
The first generation of predictive tests based on clinical risk factors and biomarkers alone or in combination with clinical risk factors will be developed in the first 2500 women recruited into SCOPE. The total sample size for further testing and validation is estimated at 10,000.

Trial website

www.scopestudy.net, 
www.maps-study.net

Trial related presentations / publications

We have had 62 SCOPE publications - a complete list has been put in as an attachment.

Public notes

Attachments [1]

/AnzctrAttachments/82254-SCOPE Consortium Publications List_uploaded_ANZCTR_151221.docx

Contacts

Principal investigator

Name

Prof Professor Louise Kenny

Address

Director, The Irish Centre for Fetal and Neonatal Translational Research
Professor of Obstetrics and Consultant Obstetrician and Gynaecologist
Department of Obstetrics and Gynaecology,
5th Floor, Cork University Maternity Hospital,
Wilton,
Cork,
IRELAND

Country

Ireland

Phone

+353 (0)21 420 5023

Fax

+353 (0)21 420 5025

[email protected]

Contact person for public queries

Name

Professor Louise Kenny

Address

Country

Ireland

Phone

+353 (0)21 420 5023

Fax

+353 (0)21 420 5025

[email protected]

Contact person for scientific queries

Name

Prof Louise Kenny

Address

Country

Ireland

Phone

+353 (0)21 420 5023

Fax

+353 (0)21 420 5025

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Risk Factors for Excessive Gestational Weight Gain in a Healthy, Nulliparous Cohort	2014	https://doi.org/10.1155/2014/148391
Embase	Cohort profile: The Cork BASELINE Birth Cohort Study: Babies after SCOPE: Evaluating the Longitudinal Impact on Neurological and Nutritional Endpoints.	2015	https://dx.doi.org/10.1093/ije/dyu157
Embase	Eating behaviour and weight status at 2 years of age: Data from the Cork BASELINE Birth Cohort Study.	2015	https://dx.doi.org/10.1038/ejcn.2015.130
Dimensions AI	Mid-Trimester Maternal ADAM12 Levels Differ According to Fetal Gender in Pregnancies Complicated by Preeclampsia	2015	https://doi.org/10.1177/1933719114537713
Embase	Compliance with National Institute of Health and Care Excellence risk-based screening for Gestational Diabetes Mellitus in nulliparous women.	2016	https://dx.doi.org/10.1016/j.ejogrb.2016.01.044
Embase	Cord blood leptin and gains in body weight and fat mass during infancy.	2016	https://dx.doi.org/10.1530/EJE-16-0431
Embase	Neonatal adiposity increases the risk of atopic dermatitis during the first year of life.	2016	https://dx.doi.org/10.1016/j.jaci.2015.05.035
Embase	The obesity associated FTO gene variant and the risk of adverse pregnancy outcomes: Evidence from the SCOPE study.	2016	https://dx.doi.org/10.1002/oby.21662
Embase	The relationship between 25-hydroxyvitamin D concentration in early pregnancy and pregnancy outcomes in a large, prospective cohort.	2016	https://dx.doi.org/10.1017/S0007114516003202
Embase	Use of metabolomics for the identification and validation of clinical biomarkers for preterm birth: Preterm SAMBA.	2016	https://dx.doi.org/10.1186/s12884-016-1006-9
Embase	Vitamin D status is associated with uteroplacental dysfunction indicated by pre-eclampsia and small-for-gestational-age birth in a large prospective pregnancy cohort in Ireland with low Vitamin D status.	2016	https://dx.doi.org/10.3945/ajcn.116.130419
Embase	Do changing levels of maternal exercise during pregnancy affect neonatal adiposity? Secondary analysis of the babies after SCOPE: Evaluating the longitudinal impact using neurological and nutritional endpoints (BASELINE) birth cohort (Cork, Ireland).	2017	https://dx.doi.org/10.1136/bmjopen-2017-017987
Embase	Impact of maternal, antenatal and birth-associated factors on iron stores at birth: Data from a prospective maternal-infant birth cohort.	2017	https://dx.doi.org/10.1038/ejcn.2016.255
Embase	Iron intakes and status of 2-year-old children in the Cork BASELINE Birth Cohort Study.	2017	https://dx.doi.org/10.1111/mcn.12320
Embase	The INSR rs2059806 single nucleotide polymorphism, a genetic risk factor for vascular and metabolic disease, associates with pre-eclampsia.	2017	https://dx.doi.org/10.1016/j.rbmo.2017.01.001
Embase	Vitamin D metabolite concentrations in umbilical cord blood serum and associations with clinical characteristics in a large prospective mother-infant cohort in Ireland.	2017	https://dx.doi.org/10.1016/j.jsbmb.2016.12.006
Embase	Antenatal vitamin D exposure and childhood eczema, food allergy, asthma and allergic rhinitis at 2 and 5 years of age in the atopic disease-specific Cork BASELINE Birth Cohort Study.	2018	https://dx.doi.org/10.1111/all.13590
Embase	Antenatal Vitamin D Status Is Not Associated with Standard Neurodevelopmental Assessments at Age 5 Years in a Well-Characterized Prospective Maternal-Infant Cohort.	2018	https://dx.doi.org/10.1093/jn/nxy150
Embase	Exploring the concept of functional Vitamin D deficiency in pregnancy: Impact of the interaction between 25-hydroxyVitamin D and parathyroid hormone on perinatal outcomes.	2018	https://dx.doi.org/10.1093/ajcn/nqy150
Embase	Social, biological, behavioural and psychological factors related to physical activity during early pregnancy in the Screening for Pregnancy Endpoints (Cork, Ireland) cohort study.	2019	https://dx.doi.org/10.1136/bmjopen-2018-025003
Embase	Sex- and growth-specific characteristics of small for gestational age infants: a prospective cohort study.	2020	https://dx.doi.org/10.1186/s13293-020-00300-z
Embase	Behavioral consequences at 5 y of neonatal iron deficiency in a low-risk maternal-infant cohort.	2021	https://dx.doi.org/10.1093/ajcn/nqaa367
Embase	Glycerophospholipid and detoxification pathways associated with small for gestation age pathophysiology: discovery metabolomics analysis in the SCOPE cohort.	2021	https://dx.doi.org/10.1007/s11306-020-01740-9
Embase	Elevated Maternal Folate Status and Changes in Maternal Prolactin, Placental Lactogen and Placental Growth Hormone Following Folic Acid Food Fortification: Evidence from Two Prospective Pregnancy Cohorts.	2023	https://dx.doi.org/10.3390/nu15071553

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically