NCT02782650

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 counseling.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

May 10, 2016

Last Update Submit

May 24, 2016

Conditions

Keywords

LimitsPrenatal CounselingDecision-makingFoetal ComplicationsCounselingViability

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • differences between neonatologists and obstetricians

    during the time of the survey (july 2012 - dec 2013)

Study Arms (1)

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

Interventions

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

Survey and interviews

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • member of the study group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Premature Birth

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Marije Hogeveen, MD, PhD

    Radboud University Medical Center

    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

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 25, 2016

Record last verified: 2016-05