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Completed

NCT Number: NCT03795857

Antenatal Palliative Care

In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.

The aim of the study is to describe parents' experience for a better understanding and a better care.

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Key information

Conditions

Fetal Death Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Female Urogenital Diseases and Pregnancy Complications Fetal Anomaly Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon, Bron, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The woman must be between the ages of 18 and 50 and the adult,
  • Participants must have received the information and not have objected to participating in the study,
  • the lethal / adverse short-term prognosis of the fetal pathology must have been confirmed by a committee of experts (CPDPN),
  • The choice to continue the pregnancy should have been clearly expressed,
  • The birth of the child should not be older than 24 months.
  • The child's death must be more than 6 months old (or not have occurred)

Exclusion criteria

  • Non-mastery of the French language,
  • Measure of legal protection of one of the members of the couple (guardianship, trusteeship, ...),
  • Severe psychiatric or neurological disorders inducing significant cognitive impairment.

Treatment and study plan

semi-structured interviews

Behavioral

The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.

Primary outcomes

  1. Description of the pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis

    Time frame: About 1 hour and 30 minutes

    The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.

Acronym: SPAN

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2019
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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