Prenatal Counseling in Extreme Prematurity: Professionals' View (PreCo-profs)

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Extremely Premature Infants
• Intervention / Treatment: Other: survey and interview

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

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 Type: Observational
• Enrollment (Actual): 122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All (fellow) neonatologists OR (fellow) obstetricians from one of the 10 specialized perinatal care centers in the Netherlands

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Survey and interviews; * part one * (quantitative) Survey on: A) prenatal counseling at the limits of viability, both current and preferred, within three domains of interest: organization of prenatal counseling; content of prenatal counseling; decision-making in prenatal counseling B) treatment options at the limits of viability against the background of the Dutch guideline * part two * (qualitative) Focus groups 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
current and preferred prenatal counseling practices in 3 domains (organization, content, decision-making)	during the time of the survey (july 2012 - dec 2013)
preferences in treatment decisions (organization, content, decision-making)	during the time of the survey (july 2012 - dec 2013)
qualitative explored specific preferences in content, influencing factors on organization and decision-making	during focus group interviews (may - july 2015)

Secondary Outcome Measures

Outcome Measure	Time Frame
differences between neonatologists and obstetricians	during the time of the survey (july 2012 - dec 2013)

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Amsterdam UMC, location VUmc; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Leiden University Medical Center; Maxima Medical Center; Isala; Maastricht universitair medisch centrum, Maastricht
• Investigators: Principal Investigator: Marije Hogeveen, MD, PhD, Radboud University Medical Center

Publications and helpful links

General Publications

• Geurtzen R, Van Heijst A, Hermens R, Scheepers H, Woiski M, Draaisma J, Hogeveen M. Preferred prenatal counselling at the limits of viability: a survey among Dutch perinatal professionals. BMC Pregnancy Childbirth. 2018 Jan 3;18(1):7. doi: 10.1186/s12884-017-1644-6. Erratum In: BMC Pregnancy Childbirth. 2018 Feb 19;18(1):54.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Counseling; Decision-making; Viability; Prenatal Counseling; Limits; Foetal Complications
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: Preco-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: available upon request