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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12607000551493
Acronym
SCOPE; (Also known in the in the United Kingdom as MAPS in Ireland as SCOPE Ireland).
Enrollment
5690
Registered
2007-10-26
Start date
2004-11-11
Completion date
2011-02-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Associate Professor Robyn North
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
-2147483648 No limit to -2147483648 No limit
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: May 15, 2026