|- candidate number||12097|
|- NTR Number||NTR3367|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-mrt-2012|
|- Secondary IDs||2012-322 MEC ErasmusMC|
|- Public Title||Healthy Pregnancy 4 All: Onderdeel risicoselectie in de zwangerschap.|
|- Scientific Title||Systematic antenatal risk selection to prevent adverse pregnancy outcomes with the R4U scorecard and corresponding care pathways (Healthy Pregnancy 4 All): A cluster randomised controlled trial in 14 selected municipalities in the Netherlands with an adverse perinatal profile. |
|- ACRONYM||Healthy Pregnancy 4 All|
|- hypothesis||1. To investigate the effectiveness of systematic approach in antenatal healthcare (by means of the R4U score card, care pathways and multidisciplinary collaboration) on adverse pregnancy outcomes;|
2. To assess the efficacy of implementation on the R4U and care pathways.
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Preterm infants, Risk selection, Intra uterine growth retardation/restriction|
|- Inclusion criteria||All pregnant women (singleton or multiple) in selected postal code areas within the 14 selected municipalities, who have their initial booking visit with their midwife or gynaecologist. |
|- Exclusion criteria||1. No informed consent given;|
2. (Suspected) miscarriage, missed abortion, or in labour at booking visit.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||31-mrt-2014|
|- Target number of participants||7000|
|- Interventions||The intervention comprises of systematic risk selection with the Rotterdam Reproductive Risk Reduction (R4U) score card in pregnant women at the initial booking visit. A predefined threshold, based on weighed risk factors derived from the R4U, determines assessment between different professionals in healthcare, social care and local agencies. Care pathways for both medical and non-medical risk factors are developed. All care pathways correspond to risk factors incorporated in the R4U. The created care pathways can be used for two purposes. First, they could support the individual health care professional to encounter complex (non-) medical risk factors. Secondly, they could assist in the collaboration between different health care professionals to encounter potentially high risk pregnancies by means of a standard approach.|
The main purpose of the intervention is to improve perinatal outcomes through early recognition of potential high risk pregnancies and improved collaboration.
In the control group, antenatal health care will not be interfered.
Data regarding pregnancy and childbirth will be compared between both groups.
|- Primary outcome||The main outcomes are small for gestational age (birthweight < p10), preterm birth (<37 weeks), and efficacy of implementation.|
Data regarding birthweight and preterm birth will be obtained from medical records. Efficacy will be measured by the number of R4Us filled out by the health care professional. Data regarding risk guided use of care pathways, actually performed multidisciplinary assessment and patient and healthcare professional satisfaction will be obtained from several questionnaires.
|- Secondary outcome||1. Prevalence of perinatal mortality (subdivided in fetal and neonatal mortality) and low apgar score (<7 after 5 minutes), which will be obtained from medical records;|
2. Antenatal detection rate of small for gestational age and unexpected preterm births (according to place of birth and responsible healthcare professional), obtained from questionnaires and medical records;
3. Distribution of non-medical risk factors according to some population based characteristics (both separately and combined) obtained from the R4U.
|- Timepoints||In April 2012, METC approval will be requested.
Randomization to predefine intervention and control municipalities took place in January 2012, and was performed by an independent statistician.
In the intervention group, the R4U will be filled out by a midwife or gynaecologist during the initial booking visit. Four weeks after delivery, information regarding pregnancy and childbirth will be obtained (CRF). In addition, health care professionals will fill in questionnaires regarding collaboration and satisfaction every 6 months.
In the control group, data regarding pregnancy and childbirth will be obtained (CRF) if informed consent was given. |
|- Trial web site||www.erasmusmc.nl/HP4ALL|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Amber Vos|
|- CONTACT for SCIENTIFIC QUERIES|| Semiha Denktas|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Obstetrics and Gynecology|
(Source(s) of Monetary or Material Support)
|Ministry of Health, Welfare and Sports|
|- Brief summary||Unfavourable pregnancy outcomes, new findings regarding non-medical risk factors associated with adverse outcomes (eg. social status, lifestyle or ethnicity), risk cumulation, and insufficient tools to optimize early detection of potential risk factors associated with adverse pregnancy outcomes have emphasized the need for a new approach in antenatal health care.|
To tackle these problems, a new tool for systemic antenatal risk selection was developed: The Rotterdam Reproductive Risk Reduction (R4U) score card. In addition, corresponding care pathways were created to encounter detected risk factors.
The main purpose of this new approach is to improve perinatal outcomes through early recognition of potential high risk pregnancies and improved collaboration within antenatal healthcare and other (local) social care services. A large cluster randomized controlled trial will be conducted to investigate the effectiveness of this new systematic approach on adverse pregnancy outcomes (primarily prematurity and small-for-gestational-age) and efficacy of implementation.
|- Main changes (audit trail)|
|- RECORD||20-mrt-2012 - 5-aug-2012|