Pre-EclampsiaPREPARENCT03073317
PREPARE, Prematurity Reduction by Pre-eclampsia Care
A study testing FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio) in people with Pre-Eclampsia and Premature Birth, run by Instituto Fernandes Figueira at 8 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia, Premature Birth
- What is being tested?
- FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 8 sitesBrazil
- Study dates
- 1 Dec 2016to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pregnancy before 16 weeks
- delivery at designed maternity center
Who cannot join
- not viable fetus
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Maternidade Unesp Botucatu
Botucatu, São Paulo, 18618-681
Caism - Unicamp
Campinas, São Paulo, 13084-881
Hospital de Clinicas de Porto Alegre
Porto Alegre, RIO GDE DO SUL, 90.035-903
Instituto Fernandes Figueira
Rio de Janeiro, 20021140
Maternidade Maria Amelia Buarque de Holanda
Rio de Janeiro, 20211-340
Maternidade Leila Diniz
Rio de Janeiro, 22775-003
Hospital Guilherme Alvaro
Santos, São Paulo, 11045-904
Hospital Maternidade Leonor Mendes de Barros
São Paulo, 03015-000
About this study
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.
Read the detailed description
This proposal (PREPARE), led by Brazilian investigators in collaboration with the Global Pregnancy Collaboration (CoLab) is centred on 7 hospital centres and their 23 satellite community health centres (UBSs). There are two clinical initiatives: First, a programme of systematic knowledge transfer (KT) to encourage adoption of the WHO Guidelines to prevent pre-eclampsia as part of routine antenatal care (Objective 1); second an intervention to reduce unnecessary preterm deliveries for the management of pre-eclampsia. CoLab investigators have developed methods to identify those women with preterm pre-eclampsia whose pregnancies can be safely prolonged.4-6 In Objective 2.1, these methods will be applied to women presenting with definite or suspected pre-eclampsia at < 37 weeks' gestation. Investigators will determine the likelihood of an imminent adverse outcome in these women using Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio (sFlT-1/PlGF) measurement and fullPIERS clinical assessment. Prior studies with these approaches indicate more than 98% negative predictive value for adverse outcomes for both.4-6 Investigators will delay delivery in those whose risk is low, caring for patients in accordance with evidence-based WHO guidelines.Unlike medications, management cannot be tested in a blinded way. Management needs integrated skills and commitment from caregivers. Hence, a standard randomized controlled trial is inappropriate. Instead investigators propose a Stepped Wedge Design to study outcomes in the 7 geographically diverse study centres, throughout Brazil. At least 6 women with preterm pre-eclampsia will deliver at each centre every month. The primary outcome will be a lower rate of PRETERM BIRTH due to pre-eclampsia as a proportion of total deliveries in the centre(s) after implementation of the plan compared to prior to its introduction. The study will have 80% power to demonstrate a 25% reduction (2.0 - 1.5%). Investigators will assess maternal and foetal adverse events as secondary outcomes. Objective 2.2 will institute an intense program of knowledge transfer to implement the new management techniques. In Objectives 2.3 and 2.4 will determine patient and provider satisfaction and the economic impact of the care plan. In Objective 3 will establish a biobank and database to begin to assess demographic factors and biological analytes that may help identify unique predictive and diagnostic/pathophysiological features for pre-eclampsia in the Brazilian population (that may extend to other low and middle income countries (LMIC)). For two years at routine visits (≤16 weeks, 28-32 weeks) at each UBS, relevant data and plasma, serum, urine and DNA samples will be stored to the appropriate standards in the biorepository (at least 7000 cases). Investigators estimate that will acquire samples at delivery in at least 5000 of these women. For four years, biological samples from women with pre-eclampsia or other adverse outcomes and 2 matched controls will be collected at admission for labour (an additional 3,000 subjects). Objective 4 will initiate pilot studies to identify novel biomarkers, and compare these and other known pathophysiological factors with those from LMIC (Africa, India) and HIC using samples from CoLab. Additional funding will be sought for expansion and validation (e.g. Merck for Mothers). Investigators will also seek funding to address risk stratification in apparently low risk women, based on the samples collected at 28-32 weeks. Objective 5 will promote intellectual interactions and collaboration between the seven centres and CoLab. Ability to understand and cure complex adverse pregnancy outcomes leading to acute and long-range disability in children requires intensive collaboration across usual "silos" including hospitals and nations. The coordinators anticipate the interaction of investigators and care providers in the seven centres will foster intellectual collaboration and improved standardized care. Brazilian investigators will become members of CoLab, increasing its unique vision, expertise and resources (current data and biological materials from 28 centres). worldwide).
- Conditions
- Pre-Eclampsia, Premature Birth
- Being tested
- FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)
- Keywords
- Preterm Infants, Premature Birth, Placenta growth factor, Prenatal Care, PERINATAL MORTALITY, Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia, Premature Birth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | Clinical protocol using FullPIERS and sFlit/PLGF ratio (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio) Receives: Diagnostic Test: FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio) |
| CONTROL | No intervention | Usual clinic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
proportion of women delivered with preterm pre-eclampsia/ total deliveries for pre-eclampsia, where preterm is <37 weeks' gestation
Measured: 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
proportion of women delivered in the centres with preterm pre-eclampsia (deliveries with preterm pre-eclampsia/ total deliveries), where preterm is <34 weeks' gestation
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
RATE PRETERM PRE-ECLAMPSIA DELIVERIES
proportion of women delivered with preterm pre-eclampsia/ total deliveries for pre-eclampsia, where preterm is <34 weeks' gestation
Measured: 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
4a. HELLP syndrome cases of HELLP syndrome in women with pre-eclampsia
4b. pulmonary oedema cases of pulmonary oedema in women with pre-eclampsia
4c. eclampsia proportion of women with eclampsia
4d. cerebrovascular accident (CVA) cases of maternal cerebrovascular accident (stroke or coma) in women with pre-eclampsia
4e. renal dysfunction cases of renal dysfunction in women with pre-eclampsia, where criteria is serum creatinine of >150
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
frequency of severe hypertension
systolic BP ≥ 160 mmHg or diastolic BP ≥ 110 mm/Hg
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
placental abruption
cases of placental abruption
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
mode of delivery (total C-sections)
total number of reported C-sections
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
stillbirth
cases of stillbirth at >20 weeks
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
early neonatal mortality
cases of neonatal mortality at <7 days
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
admission to the neonatal care unit
cases of admission to the neonatal care unit due to prematurity related to pre-eclampsia
Measured: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Dec 2016
- Primary completion30 Dec 2019
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- stepped-wedge cluster-randomised trial in seven clusters
- Masking
- None (open label)
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Fernandes Figueira
- Sponsor type
- Other government
- Collaborators
- CoLab, SMSDC/RJ, University of Campinas, Brazil, UPECLIN HC FM Botucatu Unesp, HGA, HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS, Hospital de Clinicas de Porto Alegre
- Responsible party
- Principal investigator, Marcos Augusto Bastos Dias, Instituto Fernandes Figueira
- Investigators
- Marcos A Dias, PhD, Principal investigator, Instituto Fernandes Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073317
- Sponsor's protocol ID
- PRES-023-PPE-15
- Acronym
- PREPARE
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2017
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18280875Redman CW, Sargent IL. Latest advances in understanding preeclampsia. Science. 2005 Jun 10;308(5728):1592-4. doi: 10.1126/science.1111726.
PubMed 15947178WHO 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/
PubMed 23741776Zeisler 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.
PubMed 26735990von 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.
PubMed 21185591Dantas 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.
PubMed 23927768Kajantie 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.
PubMed 19265049Passini 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.
PubMed 20482822Camargo 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.
PubMed 24215470Chappell 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.
PubMed 25861796Vigil-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.
PubMed 23954534von Dadelszen P, Magee LA, Roberts JM. Subclassification of preeclampsia. Hypertens Pregnancy. 2003;22(2):143-8. doi: 10.1081/PRG-120021060.
PubMed 12908998Brown 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.
PubMed 17092344Hussey 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.
PubMed 16829207Harvey 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.
PubMed 11879422
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE, Prematurity Reduction by Pre-eclampsia Care
- ClinicalTrials.gov ID
- NCT03073317
- Acronym / sponsor ID
- PREPARE / PRES-023-PPE-15
- Conditions
- Pre-Eclampsia, Premature Birth
- Keywords
- Preterm Infants, Premature Birth, Placenta growth factor, Prenatal Care, PERINATAL MORTALITY, Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Instituto Fernandes FigueiraOther government
- Collaborators
- CoLab, SMSDC/RJ, University of Campinas, Brazil, UPECLIN HC FM Botucatu Unesp, HGA, HOSPITAL MATERNIDADE LEONOR MENDES DE BARROS, Hospital de Clinicas de Porto Alegre
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposal (PREPARE), led by Brazilian investigators in collaboration with the Global Pregnancy Collaboration (CoLab) is centred on 7 hospital centres and their 23 satellite community health centres (UBSs). There are two clinical initiatives: First, a programme of systematic knowledge transfer (KT) to encourage adoption of the WHO Guidelines to prevent pre-eclampsia as part of routine antenatal care (Objective 1); second an intervention to reduce unnecessary preterm deliveries for the management of pre-eclampsia. CoLab investigators have developed methods to identify those women with preterm pre-eclampsia whose pregnancies can be safely prolonged.4-6 In Objective 2.1, these methods will be applied to women presenting with definite or suspected pre-eclampsia at < 37 weeks' gestation. Investigators will determine the likelihood of an imminent adverse outcome in these women using Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio (sFlT-1/PlGF) measurement and fullPIERS clinical assessment. Prior studies with these approaches indicate more than 98% negative predictive value for adverse outcomes for both.4-6 Investigators will delay delivery in those whose risk is low, caring for patients in accordance with evidence-based WHO guidelines.Unlike medications, management cannot be tested in a blinded way. Management needs integrated skills and commitment from caregivers. Hence, a standard randomized controlled trial is inappropriate. Instead investigators propose a Stepped Wedge Design to study outcomes in the 7 geographically diverse study centres, throughout Brazil. At least 6 women with preterm pre-eclampsia will deliver at each centre every month. The primary outcome will be a lower rate of PRETERM BIRTH due to pre-eclampsia as a proportion of total deliveries in the centre(s) after implementation of the plan compared to prior to its introduction. The study will have 80% power to demonstrate a 25% reduction (2.0 - 1.5%). Investigators will assess maternal and foetal adverse events as secondary outcomes. Objective 2.2 will institute an intense program of knowledge transfer to implement the new management techniques. In Objectives 2.3 and 2.4 will determine patient and provider satisfaction and the economic impact of the care plan. In Objective 3 will establish a biobank and database to begin to assess demographic factors and biological analytes that may help identify unique predictive and diagnostic/pathophysiological features for pre-eclampsia in the Brazilian population (that may extend to other low and middle income countries (LMIC)). For two years at routine visits (≤16 weeks, 28-32 weeks) at each UBS, relevant data and plasma, serum, urine and DNA samples will be stored to the appropriate standards in the biorepository (at least 7000 cases). Investigators estimate that will acquire samples at delivery in at least 5000 of these women. For four years, biological samples from women with pre-eclampsia or other adverse outcomes and 2 matched controls will be collected at admission for labour (an additional 3,000 subjects). Objective 4 will initiate pilot studies to identify novel biomarkers, and compare these and other known pathophysiological factors with those from LMIC (Africa, India) and HIC using samples from CoLab. Additional funding will be sought for expansion and validation (e.g. Merck for Mothers). Investigators will also seek funding to address risk stratification in apparently low risk women, based on the samples collected at 28-32 weeks. Objective 5 will promote intellectual interactions and collaboration between the seven centres and CoLab. Ability to understand and cure complex adverse pregnancy outcomes leading to acute and long-range disability in children requires intensive collaboration across usual "silos" including hospitals and nations. The coordinators anticipate the interaction of investigators and care providers in the seven centres will foster intellectual collaboration and improved standardized care. Brazilian investigators will become members of CoLab, increasing its unique vision, expertise and resources (current data and biological materials from 28 centres). worldwide).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- stepped-wedge cluster-randomised trial in seven clusters
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Diagnostic Test: FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)Clinical protocol using FullPIERS and sFlit/PLGF ratio (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio) |
| CONTROL | No intervention | –Usual clinic control |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- pregnancy before 16 weeks
- delivery at designed maternity center
Key exclusion criteria (1 listed)
- not viable fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)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. | Diagnostic test | INTERVENTION |
Primary outcome
patients with preterm preeclampsia
Time frame: 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 (deliveries with preterm pre-eclampsia/ total deliveries), where preterm is <37 weeks' gestation
10 secondary outcomes
proportion of women delivered in the centers who delivered prematurely
Time frame: 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
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
RATE PRETERM PRE-ECLAMPSIA DELIVERIES
Time frame: 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
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
frequency of severe hypertension
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
placental abruption
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
mode of delivery (total C-sections)
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
stillbirth
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
early neonatal mortality
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
admission to the neonatal care unit
Time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Background: PubMed 18280875Ananth 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.
- Results publication: PubMed 15947178Redman CW, Sargent IL. Latest advances in understanding preeclampsia. Science. 2005 Jun 10;308(5728):1592-4. doi: 10.1126/science.1111726.
- Results publication: PubMed 23741776WHO 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/
- Results publication: PubMed 26735990Zeisler 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.
- Results publication: PubMed 21185591von 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.
- Results publication: PubMed 23927768Dantas 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.
- Results publication: PubMed 19265049Kajantie 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.
- Results publication: PubMed 20482822Passini 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.
- Results publication: PubMed 24215470Camargo 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.
- Results publication: PubMed 25861796Chappell 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.
- Results publication: PubMed 23954534Vigil-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.
- Results publication: PubMed 12908998von Dadelszen P, Magee LA, Roberts JM. Subclassification of preeclampsia. Hypertens Pregnancy. 2003;22(2):143-8. doi: 10.1081/PRG-120021060.
- Individual participant dataSharing planned: No
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Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcos A Dias, PhD principal investigator
Instituto Fernandes Figueira
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio) in people with Pre-Eclampsia and Premature Birth, run by Instituto Fernandes Figueira at 8 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients with preterm preeclampsia (time frame: researchers will be assessing and reporting outcome through month 1 to month 34 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073317, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.