Pertinence of Pediatric Message Delivered to Parents During Antenatal Consultations

Information Understanding and Psychological Impact Clinical Trial

— INFONEO  

Official title:

Pertinence of Pediatric Message Delivered to Parents During Antenatal Consultations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008641
• Other study ID #: PSS2018/INFONEO-HASCOET/NK
• Status: Completed
• Start date: February 13, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Antenatal consultations are experienced as traumatic for many couples. Moreover, when informations are given urgently ; comprehension and psychological impact aren't well evaluate.

This project aims to evaluate comprehension and psychological impact, for both members of the couple, when informations are provided urgently or during usual consultations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parents whom pregnancies need antenatal pediatric consultation

• Non opposition

Exclusion Criteria:

• < 18 years old

• Psychiatric illness

Related Conditions & MeSH terms

• Information Understanding and Psychological Impact

Intervention

Other:
• Pediatric consultation's survey
Realization of a pediatric consultation. At the end, evaluation of comprehension and psychological impact with a survey (completed by parents).

Locations

Country	Name	City	State
France	CHRU Nancy - Maternité Régionale	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension and psychological impact ; urgently informations compared with usual consultations	After non opposition, surveys are given to parents; Scale built by investigators. With items about comprehension and psychological impact. From 0 to 23. One point per item. Higher values (23/23) represent a better outcome (comprehension and good psychological impact (0/23 if not)).	At pregnancy follow-up visit up to 36 weeks gestation
Secondary	Difference between both members of the couple	Same survey for both members, evaluation and comparison of answers.; Same scale	At pregnancy follow-up visit up to 36 weeks gestation
Secondary	Comprehension and psychological impact, at pregnancy's theoric term compared with first survey Same scale	Same survey, realized at pregnancies' theoric terms	At delivery at 41 weeks gestation