Prenatal Counseling in Extreme Prematurity: Parents' View

Complications Clinical Trial

— PreCo-parents  

Official title:

Prenatal Counseling in Extreme Prematurity: Parents' View

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782637
• Other study ID #: Preco-2
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: May 24, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• 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 counselling.

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, being the parents The PreCo study amongst parents has three major aims

1. to find initial preferences among Dutch experienced parents on prenatal counseling at the limits of viability (quantitatively)

2. to evaluate decision-making among Dutch experienced parents at the limits of viability (quantitatively)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The study population consists of the cohort 01-10-2010 to 01-10-2013 of parents who were confronted with the birth of an extremely preterm infant with a gestational age between 24 and 25 weeks, after the introduction of the new Dutch guideline in October 2010.

Exclusion Criteria:

• birth at 24-25 weeks of gestation due to active termination of pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Complications
• Extreme Prematurity
• 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: individual interviews to further perform in-depth exploration of prenatal counseling preferences

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
Radboud University	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Fonds NutsOhra, 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 (march 2015 - march 2016)	No
Primary	evaluation of the decision made (decisional conflict and regret)		during the time of the survey (march 2015 - march 2016)	No
Primary	qualitative explored specific preferences in content, influencing factors on organization and decision-making		during the interviews (may - june 2015)	No