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First trimester screening for pre-eclampsia and intrauterine growth restriction using three-dimensional Doppler angiography (SPIRIT): protocol for a multicentre prospective study in nulliparous pregnant women
- Source :
- BMJ Open, Vol 10, Iss 10 (2020), BMJ Open, BMJ Open, BMJ Publishing Group, 2020, 10 (10), pp.e037751. ⟨10.1136/bmjopen-2020-037751⟩
- Publication Year :
- 2020
- Publisher :
- BMJ Publishing Group, 2020.
-
Abstract
- IntroductionPre-eclampsia (PE) and intrauterine growth restriction (IUGR) are two major pregnancy complications, related to chronic uteroplacental hypoperfusion. Nowadays, there is no screening or diagnostic test for uteroplacental vascularisation deficiency in pregnant women. Since 2004, 3 three-imensional power Doppler (3DPD) angiography has been used for the evaluation of uteroplacental vascularisation and three vascular indices are usually calculated: Vascularisation Index (VI), Flow Index (FI) and vascularisation-FI (VFI). A high intraobserver and interobserver reproducibility and a potential interest for placental function study were reported by our team and others.The main objective of our study is to determine differences in 3DPD indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE (mild and severe) and IUGR in nulliparous women.Methods and analysisThis is a national multicentre prospective cohort study conducted in four French maternity units. We expect to include 2200 women in a period of 36 months. The nulliparous pregnant women will be recruited during their first trimester consultation (11–13+6 gestation week (GW)).The 3DPD and uterine artery Doppler acquisition will be included in the current routine 11–13+6 GW ultrasound. Also, additional blood samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection. Uteroplacental VIs (FI and VFI) will be measured. For each subgroup (uncomplicated pregnancy, PE and IUGR), mean values in 3DPD indices will be computed and compared using a pairwise t test with a Bonferroni correction p value adjustment.Ethics and disseminationThe study was approved by the French Ethics Committee, the Comité de Protection des Personnes SUD MEDITERRANEE IV on 13 February 2018 with reference number 17 12 03. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.Trial registration numberNCT03342014; Pre-results. PHRCN-16-0567.
- Subjects :
- fetal medicine
Placenta
[INFO.INFO-IM] Computer Science [cs]/Medical Imaging
Intrauterine growth restriction
0302 clinical medicine
Pre-Eclampsia
Pregnancy
Obstetrics and Gynaecology
Multicenter Studies as Topic
030212 general & internal medicine
Prospective Studies
Prospective cohort study
030219 obstetrics & reproductive medicine
Fetal Growth Retardation
[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology
medicine.diagnostic_test
Obstetrics
ultrasound
Angiography
General Medicine
ultrasonography
3. Good health
Gestation
Medicine
Female
medicine.medical_specialty
Prenatal diagnosis
[SDV.IB.MN]Life Sciences [q-bio]/Bioengineering/Nuclear medicine
Ultrasonography, Prenatal
[SDV.IB.MN] Life Sciences [q-bio]/Bioengineering/Nuclear medicine
03 medical and health sciences
Imaging, Three-Dimensional
medicine
[INFO.INFO-IM]Computer Science [cs]/Medical Imaging
Humans
Eclampsia
prenatal diagnosis
business.industry
Reproducibility of Results
Ultrasonography, Doppler
medicine.disease
First trimester
Pregnancy Trimester, First
Pregnant Women
business
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 10
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....ffc9061f0c10680a654d1ca641101bd5