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Clinical Trial Summary

This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm birth including current and preferred counseling, barriers and facilitators for preferred counseling from both obstetricians and neonatologists, as well as parents' views on this.

Since 2010, intensive care can be offered in the Netherlands at 24+0 weeks gestation (with parental consent) but as some international guidelines, the Dutch guideline lacks detailed recommendations on organization, content and preferred decision-making of the counseling.


Clinical Trial Description

The anticipated delivery of an infant at the limits of viability presents parents and professionals with medical, ethical and emotional issues; especially when a decision on the initiation of care has to be made. Since the first publication in 2002 by the American Academy of Pediatrics several (albeit different) guidelines and recommendations on periviability counseling have been published. However, there is no universally accepted way of performing prenatal counseling and, consequently, studies describe heterogeneous counseling practices worldwide.

Some guidelines on resuscitation at the limits of viability include recommendations on the parental involvement in the decision-making. Nevertheless, the extent of involvement and the gestational age (GA) at which parents should be involved, varies. In 2010, the Dutch guideline on perinatal practice in extremely premature delivery lowered the limit offering intensive care from 25+0 to 24+0 weeks GA. Just as some international guidelines include a role for parents at the limits of viability, the Dutch guideline states that at 24 weeks GA informed consent of parents is required when initiating intensive care28. Although the guideline acknowledges the importance of prenatal counseling, recommendations on organization, content or decision-making of the counseling are very limited.

Although recommendations on counseling do exist, they may not be generally applicable in the Netherlands since cross-cultural differences in perinatal practices, healthcare organization, and physician and patient views are likely to exist. To compose a national framework on prenatal counseling at the limits of viability, the nationwide PreCo study (Prenatal Counseling in Prematurity) was designed, examining both professional and parental views. High quality of care originates when no differences exist between preferred and current counseling with uniformity between the involved caregivers (obstetricians and neonatologists) and specified to the needs of those receiving counseling

The PreCo study amongst professionals has three major aims

1. to find initial preferences among Dutch perinatal professionals (neonatologists and obstetricians) on prenatal counseling at the limits of viability (quantitatively)

2. to investigate Dutch physicians' preferences on decisions about treatment options for an extremely premature neonate against the background of the Dutch guideline.(quantitatively)

3. to perform in-depth exploration of counseling preferences amongst Dutch perinatal professionals (qualitatively) ;


Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT02782650
Study type Observational
Source Radboud University
Contact
Status Completed
Phase N/A
Start date July 2012
Completion date July 2015

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