Prenatal Counseling in Extreme Prematurity: Parents' View

NCT02782637 | Completed DMC

• 1 other identifier: Preco-2
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Extreme Prematurity; Complications

Keywords

limits of viability; Prenatal Counseling; Decision-making; Viability; Counseling

Outcome Measures

Primary Outcomes (3)

• current and preferred prenatal counseling practices in 3 domains (organization, content, decision-making)

  during the time of the survey (march 2015 - march 2016)

• evaluation of the decision made (decisional conflict and regret)

  during the time of the survey (march 2015 - march 2016)

• qualitative explored specific preferences in content, influencing factors on organization and decision-making

  during the interviews (may - june 2015)

Study Arms (1)

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.

Other: survey and interview

Interventions

survey and interview 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

Survey and interviews

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• UMC Utrecht: collaborator
• Leiden University Medical Center: collaborator
• Erasmus Medical Center: collaborator
• Maastricht universitair medisch centrum, Maastricht: collaborator
• Isala: collaborator
• University Medical Center Groningen: collaborator
• Maxima Medical Center: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Fonds NutsOhra: collaborator

MeSH Terms

Interventions

Surveys and Questionnaires; Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marije Hogeveen, MD, PhD

  Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 25, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05