Prenatal Counseling in Extreme Prematurity: Professionals' View

Premature Birth Clinical Trial

— PreCo-profs  

Official title:

Prenatal Counseling in Extreme Prematurity: Professionals' View

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782650
• Other study ID #: Preco-1
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: May 24, 2016
• Start date: July 2012
• Est. completion date: July 2015

Study information

• Verified date: May 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Observational

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (fellow) neonatologist OR (fellow) obstetrician from one of the 10 specialized perinatal care centers in the Netherlands

Exclusion Criteria:

• member of the study group

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Extremely Premature Infants
• Premature Birth

Intervention

Other:
• survey and interview
all participants: survey on prenatal counseling and treatment decisions at the limits of viability. a selection of participants: focus group interviews to further perform in-depth exploration of prenatal counseling preferences

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Radboud University	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Isala Klinieken, Zwolle, Leiden University Medical Center, Maastricht universitair medisch centrum, Maastricht, Maxima Medical Center, UMC Utrecht, University Medical Center Groningen, VU University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	current and preferred prenatal counseling practices in 3 domains (organization, content, decision-making)		during the time of the survey (july 2012 - dec 2013)	No
Primary	preferences in treatment decisions (organization, content, decision-making)		during the time of the survey (july 2012 - dec 2013)	No
Primary	qualitative explored specific preferences in content, influencing factors on organization and decision-making		during focus group interviews (may - july 2015)	No
Secondary	differences between neonatologists and obstetricians		during the time of the survey (july 2012 - dec 2013)	No