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Voorspellen van de individuele kans op zwangerschapscomplicaties met behulp van een risico-analyse instrument


- candidate number15304
- NTR NumberNTR4143
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-aug-2013
- Secondary IDs13-4-053 METC azM/UM
- Public TitleVoorspellen van de individuele kans op zwangerschapscomplicaties met behulp van een risico-analyse instrument
- Scientific TitleExternal validity and impact of first-trimester obstetric prediction rules in the Netherlands.
- ACRONYMEXPECT study
- hypothesisFirst-trimester obstetric prediction rules can lead to improved outcomes for mother and child if they can guide effective actions that are tailored to individual risk profiles.
- Healt Condition(s) or Problem(s) studiedPre-eclampsia, Gestational diabetes, Preterm birth, Failure to thrive, Large for gestational age
- Inclusion criteria- Gestational age <16 weeks
- Maternal age 18 years or older
- Exclusion criteria- Gestational age >15+6 weeks
- Maternal age <18 years
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-dec-2012
- planned closingdate1-dec-2016
- Target number of participants5500
- InterventionsPhase 1: No intervention
Phase 2: Application of first-trimester obstetric prediction rules followed by tailored care paths
- Primary outcomePrimary outcome measure is a composite measure of perinatal death, asphyxia, admission to a neonatal intensive care unit, small-for-gestational-age p2.3 and very preterm birth (<32 weeks).
- Secondary outcome- Severe preeclampsia (leading to delivery before the 34th completed week)
- Maternal patient satisfaction
- Maternal health-related quality of life
- Small-for-gestational age ( - Preterm birth (<37 weeks)
- Instrumental delivery (including caesarean sections)
- Process indicators
- Costs
- TimepointsPhase 1 External validation: 01-12-2012 till 01-03-2015
Phase 2 Impact study: 01-03-2015 till 01-12-2016
Phase 1: online questionnaire before 16 weeks of gestation. Primary outcomes Phase 1 and 2: patient questionnaire (4 weeks postpartum) and patient records. Maternal satisfaction, quality of life and costs: a representative sample of participants (n=300) will be asked to fill out three additional questionnaires (~24 weeks, ~34 weeks and 4 weeks postpartum)
- Trial web sitewww.zwangerinlimburg.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD/MSc P. van Montfort
- CONTACT for SCIENTIFIC QUERIESDr. L.J.M. Smits
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale: First-trimester risk selection may benefit from the use of obstetric prediction rules. A number of first-trimester prediction models have been published, addressing important obstetric outcomes including preterm birth, preeclampsia, gestational diabetes mellitus, small-for-gestational-age and large-for-gestational-age. None of them have however been externally validated (for the Dutch situation). Furthermore, it is not clear whether the use of such prediction rules improves child and maternal outcomes, and how costs are affected. Objectives: 1) To evaluate the predictive performance of promising first-trimester obstetric prediction rules, containing variables that are easily obtainable without any additional costs (history and/or routine antenatal tests), published in the literature. 2) To compare performances of first-trimester obstetric prediction rules with similar health outcomes. 3) To determine the best cut-off values for application of the prediction rules in Dutch obstetric care. 4) To measure the effects of applying first-trimester obstetric prediction rules followed by tailored care paths in Dutch obstetric practice, as compared to care-as-usual. 5) To evaluate cost-effectiveness of applying first-trimester obstetric prediction rules followed by tailored care paths in Dutch obstetric practice, as compared to care-as-usual.

Design: The EXPECT project is a Dutch, multicenter, prospective cohort study that compromises a validation study and an impact study. In the validation study, we will evaluate the predictive performance of promising first-trimester obstetric prediction rules published in the literature. In the impact study, we will evaluate outcomes and costs after applying 1st-trimester prediction rules followed by tailored care paths, and compare these with outcomes and costs during care-as-usual.

Participants: Eligible for both the validation and the impact study are pregnant women who pay their initial visit to a midwive or gynecologist participating in the Limburg Obstetric Consortium. Exclusion criteria: gestational age >15+6 weeks and age <18 years. A total of 2 x 2750 women will be recruited.

Sample size: phase 1 n=2750 and phase 2 n=2750

Main study outcomes: Composite outcome of perinatal death, asphyxia, admission to a neonatal intensive care unit, small-for-gestational-age p2.3, and very preterm birth (<32wks).

Data sources: online questionnaires and patient records.

Analysis: Predictive performance of each prediction rule will be evaluated by assessing the area under the receiver operating characteristic curve (AUC) and model calibration. Final selection of prediction rules and definition of cut-off points will be combined with the definition of tailored care paths for the impact study. Outcomes in the two study arms will be compared by use of either logistic regression or linear regression. Economic analysis: two incremental cost-effectiveness ratios will be calculated expressing 1) the cost per one composite adverse outcome prevented and 2) the cost per Quality Adjusted Life year (mother unit of analysis).

Discussion: first-trimester obstetric prediction rules can lead to improved outcomes for mother and child if they can guide effective actions that are tailored to individual risk profiles.

Time schedule (48 months): preparation time (1-6), recruitment and follow-up phase 1 (7-21), analysis, selection of prediction rules and determination cut-off-points 6 months (22-27), recruitment and follow-up phase 2 (28-42), data analysis and report (43-48)
- Main changes (audit trail)4-mei-2017 MT
Amendment
Target number of participants new:
Phase 1: 2750
Phase 2: 750

Timepoints new:
Phase 1 External validation: 01-12-2012 till 31-12-2015
Phase 2 Impact study: 17-04-2017 till 31-09-2018
Phase 1: online questionnaire before 16 weeks of gestation. Primary outcomes Phase 1 and 2: patient questionnaire (4 weeks postpartum) and patient records. Maternal satisfaction, quality of life and costs: a representative sample of participants (n=750) will be asked to fill out three additional questionnaires (~24 weeks, ~34 weeks and 4 weeks postpartum).

Changes in short resume:
Time schedule (66 months): preparation time (1-6), recruitment and follow-up phase 1 (7-30), analysis, selection of prediction rules and determination cut-off-points 6 months (31-43), recruitment and follow-up phase 2 (44-60), data analysis and report (61-66) 7-mei-2017 - MT
Contact L.J.E. Meertens replaced by P. van Montfort
- RECORD21-aug-2013 - 7-mei-2017


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