Prenatal Counseling in Extreme Prematurity: Parents' View

NCT ID: NCT02782637

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-03-31

Brief 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.

Detailed 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)

Conditions

Extreme Prematurity; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Survey and interviews

*part one* (quantitative)

Survey on:

A. prenatal counseling at the limits of viability, within three domains of interest:

• organization of prenatal counseling
• content of prenatal counseling
• decision-making in prenatal counseling Domains used to evaluate current counseling and counseling preferences

B. decision-making at the limits of viability: evaluation of the made decision (decisional conflict and regret)

*part two* (qualitative)

Individual interviews (qualitative) to in-depth explore preferences in prenatal counseling

• insight in the specific preferred content of prenatal counseling.
• study influencing factors on preferences in the domains of organization and decision-making.

survey and interview

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Maastricht universitair medisch centrum, Maastricht

UNKNOWN

Sponsor Role: collaborator

Isala

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Maxima Medical Center

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Fonds NutsOhra

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marije Hogeveen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud

Other Identifiers

Preco-2

Identifier Type: -

Identifier Source: org_study_id