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Healthy Pregnancy 4 All: Onderdeel risicoselectie in de zwangerschap.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25585
Enrollment
7000
Registered
2012-03-20
Start date
2012-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Risk selection, Care pathway, Preterm birth, Intra uterine growth retardation.

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

Sponsors

Erasmus Medical Center - Department of Obstetrics and Gynaecology.
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. No informed consent given; 2. (Suspected) miscarriage, missed abortion, or in labour at booking visit.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactAmber Vos

Westzeedijk 118

a.a.vos@erasmusmc.nl+ (0)10 7038647

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)