PREPARE, Prematurity Reduction by Pre-eclampsia Care

NCT03073317 | Completed DMC

• 1 other identifier: PRES-023-PPE-15
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 8

Brief Summary

Investigators will test a novel system of integrated care, to promote the use of the WORLD HEALTH ORGANIZATION Guidelines for the management of pre-eclampsia and initiate the use of a structured risk assessment strategy to reduce the incidence of preterm delivery from pre-eclampsia by providing obstetricians with the confidence to safely defer delivery of women with pre-eclampsia, identified to be of low risk.

Conditions

Pre-Eclampsia; Premature Birth

Keywords

Preterm Infants; Premature Birth; Placenta growth factor; Prenatal Care; PERINATAL MORTALITY; Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• patients with preterm preeclampsia

  proportion of women delivered in the centres with preterm pre-eclampsia (deliveries with preterm pre-eclampsia/ total deliveries), where preterm is \<37 weeks' gestation

  researchers will be assessing and reporting outcome through month 1 to month 34 of the study

Secondary Outcomes (10)

• proportion of women delivered in the centers who delivered prematurely

  researchers will be assessing and reporting outcome through month 1 to month 34 of the study

• proportion of women delivered in the centres with preterm pre-eclampsia

  researchers will be assessing and reporting outcome through month 1 to month 34 of the study

• RATE PRETERM PRE-ECLAMPSIA DELIVERIES

  researchers will be assessing and reporting outcome through month 1 to month 34 of the study

• maternal morbidity and mortality defined as a composite of maternal mortality and features of 4a-4f

  researchers will be assessing and reporting outcome through month 1 to month 34 of the study

• frequency of severe hypertension

  researchers will be assessing and reporting outcome through month 1 to month 34 of the study

Study Arms (2)

INTERVENTION

EXPERIMENTAL

Clinical protocol using FullPIERS and sFlit/PLGF ratio (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)

Diagnostic Test: FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)

CONTROL

NO INTERVENTION

Usual clinic control

Interventions

FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio) DIAGNOSTIC_TEST

Once the centre is randomised to receive the intervention, all eligible women will have serum sFlt1/PlGF measurement performed and fullPIERS assessment and both results will be revealed to the care providers. This will include all women with pre-eclampsia or suspected pre-eclampsia cared for at the main hospital centres (and not be limited to women referred to the hospital from the community health centres). sFlt-1/PlGF will be tested by immunoassays (Roche Platform®). The result read out is provided by specific machines provided by Roche in less than one hour, which permits rapid clinical decision-making. Risk stratification using fullPIERS will be performed on tablet computers using a pre-defined risk scoring system integrated within the MedSciNet database.

INTERVENTION

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pregnancy before 16 weeks
• delivery at designed maternity center

You may not qualify if:

• not viable fetus

Sponsors & Collaborators

• Instituto Fernandes Figueira: lead
• CoLab: collaborator
• SMSDC/RJ: collaborator
• University of Campinas, Brazil: collaborator
• UPECLIN HC FM Botucatu Unesp: collaborator
• HGA: collaborator
• HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS: collaborator
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (8)

Hospital de Clinicas de Porto Alegre

Porto Alegre, RIO GDE DO SUL, 90.035-903, Brazil

Location

Maternidade Unesp Botucatu

Botucatu, São Paulo, 18618-681, Brazil

Location

Caism - Unicamp

Campinas, São Paulo, 13084-881, Brazil

Location

Hospital Guilherme Alvaro

Santos, São Paulo, 11045-904, Brazil

Location

Instituto Fernandes Figueira

Rio de Janeiro, 20021140, Brazil

Location

Maternidade Maria Amelia Buarque de Holanda

Rio de Janeiro, 20211-340, Brazil

Location

Maternidade Leila Diniz

Rio de Janeiro, 22775-003, Brazil

Location

Hospital Maternidade Leonor Mendes de Barros

São Paulo, 03015-000, Brazil

Location

Related Publications (20)

• Ananth CV, Vintzileos AM. Medically indicated preterm birth: recognizing the importance of the problem. Clin Perinatol. 2008 Mar;35(1):53-67, viii. doi: 10.1016/j.clp.2007.11.001.

  PMID: 18280875 BACKGROUND

• Redman CW, Sargent IL. Latest advances in understanding preeclampsia. Science. 2005 Jun 10;308(5728):1592-4. doi: 10.1126/science.1111726.

  PMID: 15947178 RESULT

• WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK140561/

  PMID: 23741776 RESULT

• Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennstrom M, Olovsson M, Brennecke SP, Stepan H, Allegranza D, Dilba P, Schoedl M, Hund M, Verlohren S. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

  PMID: 26735990 RESULT

• von Dadelszen P, Payne B, Li J, Ansermino JM, Broughton Pipkin F, Cote AM, Douglas MJ, Gruslin A, Hutcheon JA, Joseph KS, Kyle PM, Lee T, Loughna P, Menzies JM, Merialdi M, Millman AL, Moore MP, Moutquin JM, Ouellet AB, Smith GN, Walker JJ, Walley KR, Walters BN, Widmer M, Lee SK, Russell JA, Magee LA; PIERS Study Group. Prediction of adverse maternal outcomes in pre-eclampsia: development and validation of the fullPIERS model. Lancet. 2011 Jan 15;377(9761):219-27. doi: 10.1016/S0140-6736(10)61351-7. Epub 2010 Dec 23.

  PMID: 21185591 RESULT

• Dantas EM, Pereira FV, Queiroz JW, Dantas DL, Monteiro GR, Duggal P, Azevedo Mde F, Jeronimo SM, Araujo AC. Preeclampsia is associated with increased maternal body weight in a northeastern Brazilian population. BMC Pregnancy Childbirth. 2013 Aug 8;13:159. doi: 10.1186/1471-2393-13-159.

  PMID: 23927768 RESULT

• Kajantie E, Eriksson JG, Osmond C, Thornburg K, Barker DJ. Pre-eclampsia is associated with increased risk of stroke in the adult offspring: the Helsinki birth cohort study. Stroke. 2009 Apr;40(4):1176-80. doi: 10.1161/STROKEAHA.108.538025. Epub 2009 Mar 5.

  PMID: 19265049 RESULT

• Passini R Jr, Tedesco RP, Marba ST, Cecatti JG, Guinsburg R, Martinez FE, Nomura ML; Brazilian Network of Studies on Reproductive and Perinatal Health. Brazilian multicenter study on prevalence of preterm birth and associated factors. BMC Pregnancy Childbirth. 2010 May 19;10:22. doi: 10.1186/1471-2393-10-22.

  PMID: 20482822 RESULT

• Camargo EB, Moraes LF, Souza CM, Akutsu R, Barreto JM, da Silva EM, Betran AP, Torloni MR. Survey of calcium supplementation to prevent preeclampsia: the gap between evidence and practice in Brazil. BMC Pregnancy Childbirth. 2013 Nov 11;13:206. doi: 10.1186/1471-2393-13-206.

  PMID: 24215470 RESULT

• Chappell LC, Milne F, Shennan A. Is early induction or expectant management more beneficial in women with late preterm pre-eclampsia? BMJ. 2015 Apr 10;350:h191. doi: 10.1136/bmj.h191. No abstract available.

  PMID: 25861796 RESULT

• Vigil-De Gracia P, Reyes Tejada O, Calle Minaca A, Tellez G, Chon VY, Herrarte E, Villar A, Ludmir J. Expectant management of severe preeclampsia remote from term: the MEXPRE Latin Study, a randomized, multicenter clinical trial. Am J Obstet Gynecol. 2013 Nov;209(5):425.e1-8. doi: 10.1016/j.ajog.2013.08.016. Epub 2013 Aug 14.

  PMID: 23954534 RESULT

• von Dadelszen P, Magee LA, Roberts JM. Subclassification of preeclampsia. Hypertens Pregnancy. 2003;22(2):143-8. doi: 10.1081/PRG-120021060.

  PMID: 12908998 RESULT

• Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.

  PMID: 17092344 RESULT

• Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.

  PMID: 16829207 RESULT

• Harvey G, Loftus-Hills A, Rycroft-Malone J, Titchen A, Kitson A, McCormack B, Seers K. Getting evidence into practice: the role and function of facilitation. J Adv Nurs. 2002 Mar;37(6):577-88. doi: 10.1046/j.1365-2648.2002.02126.x.

  PMID: 11879422 RESULT

• von Dadelszen P, Sawchuck D, McMaster R, Douglas MJ, Lee SK, Saunders S, Liston RM, Magee LA; Translating Evidence-Based Surveillance and Treatment Strategies (TESS) Group. The active implementation of pregnancy hypertension guidelines in British Columbia. Obstet Gynecol. 2010 Sep;116(3):659-666. doi: 10.1097/AOG.0b013e3181eb669d.

  PMID: 20733449 RESULT

• Roberts JM, Hubel CA. The two stage model of preeclampsia: variations on the theme. Placenta. 2009 Mar;30 Suppl A(Suppl A):S32-7. doi: 10.1016/j.placenta.2008.11.009. Epub 2008 Dec 13.

  PMID: 19070896 RESULT

• Myers JE, Kenny LC, McCowan LM, Chan EH, Dekker GA, Poston L, Simpson NA, North RA; SCOPE consortium. Angiogenic factors combined with clinical risk factors to predict preterm pre-eclampsia in nulliparous women: a predictive test accuracy study. BJOG. 2013 Sep;120(10):1215-23. doi: 10.1111/1471-0528.12195. Epub 2013 Mar 21.

  PMID: 23906160 RESULT

• De Oliveira L, Roberts JM, Jeyabalan A, Blount K, Redman CW, Poston L, Seed PT, Chappell LC, Dias MAB; PREPARE trial group. PREPARE: A Stepped-Wedge Cluster-Randomized Trial to Evaluate Whether Risk Stratification Can Reduce Preterm Deliveries Among Patients With Suspected or Confirmed Preterm Preeclampsia. Hypertension. 2023 Oct;80(10):2017-2028. doi: 10.1161/HYPERTENSIONAHA.122.20361. Epub 2023 Jul 11.

  PMID: 37431663 DERIVED

• Dias MAB, De Oliveira L, Jeyabalan A, Payne B, Redman CW, Magee L, Poston L, Chappell L, Seed P, von Dadelszen P, Roberts JM; PREPARE Research Group. PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia. BMC Pregnancy Childbirth. 2019 Oct 7;19(1):343. doi: 10.1186/s12884-019-2445-x.

  PMID: 31590640 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth; Perinatal Death

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcos A Dias, PhD

  Instituto Fernandes Figueira

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: stepped-wedge cluster-randomised trial in seven clusters

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 8, 2017
• Study Start: December 1, 2016
• Primary Completion: December 30, 2019
• Study Completion: June 20, 2020
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (8)