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Study information

Healthy Pregnancy 4 All: Preconception Care and Risk Assessment during pregnancy


 

This website aims to describe the study regarding early antenatal risk assessment during pregnancy. For more information about preconception care, the other study within the Healthy Pregnancy 4 All project, please visit our website
 
Objective
The aims of the study are 1) to investigate the effectiveness of systematic approach in antenatal healthcare on adverse pregnancy outcomes (primarily prematurity and small-for-gestational-age) and 2) to assess the efficacy of implementation (measured by the number of R4Us filled by the health care professional, the performance of multidisciplinary deliberations and patient and healthcare professional satisfaction).

Study design
The study concerns a multicenter cluster randomized controlled trial. Fourteen selected municipalities in the Netherlands with an adverse perinatal profile (10 clusters) are randomly allocated to intervention (n = 3500) and control groups (n = 3500).

Study population
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.

Intervention
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.

Outcome measures
The main outcomes are small for gestational age (birthweight < p10), preterm birth (<37 weeks), and efficacy of implementation.
Secondary outcomes are perinatal mortality (subdivided in fetal and neonatal mortality), low apgar score (<7 after 5 minutes), antenatal detection rate of small for gestational age and unexpected preterm births according to place of birth and responsible healthcare professional, and the distribution of non-medical risk factors according to population based characteristics (both separately and combined).

Power/data analysis
We hypothesize that systematic antenatal risk selection, the introduction of care pathways and thereby enhanced collaboration between healthcare professionals could reduce the combined incidence of small for gestational age and prematurity from 16,5 % to 13 %. Using a two sided test (alpha error 5%, beta error 20%), and an intraclass correlation coefficient of 2,06, we need two groups of 3500 patients to demonstrate such a difference. Thus, the study aims to recruit 7000 patients.

Economic evaluation
Not applicable

Time schedule
36 months.

Projectleaders
- Prof. dr. E.A.P. Steegers, gynaecologist, Erasmus MC Rotterdam
- Dr. S. Denktas senior researcher, Erasmus MC Rotterdam
- Drs. A.J.M. Waelput, midwife, Erasmus MC Rotterdam
- Dr. L.C. de Jong-Potjer, general practitioner, Erasmus MC Rotterdam

Subsidy
Ministry of Health, Welfare and Sports

Contact (researcher)
Drs. A.A. Vos, PhD candidate, Erasmus MC Rotterdam
a.a.vos@erasmusmc.nl