Clinical trial NCT02782637: Prenatal Counseling in Extreme Prematurity: Parents' View
Official title: Prenatal Counseling in Extreme Prematurity: Parents' View
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extreme Prematurity
Complications
Keywords: limits of viability
Prenatal Counseling
Decision-making
Viability
Counseling
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: UMC Utrecht
name: Leiden University Medical Center
name: Erasmus Medical Center
name: Maastricht universitair medisch centrum, Maastricht
name: Isala
name: University Medical Center Groningen
name: Maxima Medical Center
name: Amsterdam UMC, location VUmc
name: Fonds NutsOhra
First posted: 2016-05-25
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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)

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

Primary outcomes:
measure: current and preferred prenatal counseling practices in 3 domains (organization, content, decision-making)
timeFrame: during the time of the survey (march 2015 - march 2016)
measure: evaluation of the decision made (decisional conflict and regret)
timeFrame: during the time of the survey (march 2015 - march 2016)
measure: qualitative explored specific preferences in content, influencing factors on organization and decision-making
timeFrame: during the interviews (may - june 2015)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radboud
name: Marije Hogeveen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: