Obstetrics

 
 APOSTEL VIII
 
 Dutch TRUFFLE
 
 2Close
 
 APRIL
 Highlow
 
 PC
 Quadruple P
 
 SIMPLE III
 
 Stop or Go?
 
 STRIDER
 
 SUGAR-DIP
 
 KEUZEHULP IMPLEMENTATIE
 
 INDEX
 MOTHER
 NethOSS
 Ppromexil-III
 ALLO
 AMPHIA
 APOSTEL-I
 APOSTEL-II
 APOSTEL-III
 APOSTEL-IV
 
 Apostel VI
 ASB
 CHIPS
 DIGITAT
 ECV Implementation
 EuFis
 Fluxim
 GlucoMOMS
 HTA Longterm conseq.
 HTA Preference study
 HYPITAT
 HYPITAT-II
 HyRAS (Hypitat followup)
 Implementatie Tour
 IUPC
 PIMPP
 PPROMCerclage
 PPROMEXIL
 PreCare
 PROBAAT
 PROBAAT-II
 PROBAAT-S
 ProTWIN
 SimpleII
 STAN
 TeMpOH-1
 TeMpOH-3
 TOSTI
 TOTEM
 Triple P
 TRUFFLE
 WOMB study

 ABCD-study
 BIG CHANGE
 CAMPUR
 Cancer in pregnancy
 Doula study
 ECV tocolysis
 ECV Uterine relaxation
 EuroHeartSurvey
 FRUIT
 HP4ALL-PC
 > HP4ALL-RS
 IMPACT
 INCAS
 IRIS
 Keizerlijk litteken
 MAKE
 OOPUS
 PRELHUDE
 PROMISES
 RAVEL
 SIMPLE
 STAN followup
 VET study
 VIS-project
 Wat bevalt beter
 ZAHARA II
 ZAHARA 3
 ZOBASII
 


Healthy Pregnancy 4 All risk assessment


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 www.erasmusmc.nl/HP4ALL.


Go to the Healthy Pregnancy 4 All - risk assessment 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. Denktaş 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