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Completed

NCT Number: NCT03646578

Maternal Anxiety Related to How the Pediatrician Provided Prenatal Information About Preterm Birth

Women hospitalized for preterm labor require clear information about prematurity.

This study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. This was a prospective, single-center observational study.Women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information + a booklet about prematurity given to the women at admission. The primary endpoint was the change in anxiety-state (before and after the information procedure) evaluated by the State Trait Anxiety Inventory-Y (STAI-Y).

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

CHU Amiens-Picardie

Amiens, 80054, France

About this study

Women hospitalized for preterm labor require clear information about prematurity.

This study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. Material and methods.This was a prospective, single-center observational study.Women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information

+ a booklet about prematurity given to the women at admission.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients hospitalized in the service of pregnancies and having a risk of premature delivery.
  • Term <34 SA

Exclusion criteria

  • Term ≥ 34 SA
  • no understanding of the questionnaire
  • foetus presenting a pathology or malformation that is life-threatening
  • patient presenting a risk of delivery before passing the pediatrician or presenting a risk of imminent delivery
  • patient hospitalized without risk of premature delivery.

Treatment and study plan

State of anxiety

Other

Patient anxiety assessment by STAI-Y-A self-assessment questionnaire provided before and after pediatric interview.

The assessment is given to patients upon arrival in the hospitalization service of pregnancies and again after the pediatric interview. This pediatric interview should take place between 1 and 7 days after admission to the hospital ward.The second part includes a 6-week inclusion period with assessment of patients' state of anxiety by a STAI-Y-A self-assessment questionnaire given before and after pediatric interview associated with the delivery of a written document. on prematurity.

Primary outcomes

  1. Mesure of the State of anxiety of patients with a risk of premature delivery

    Time frame: 3months

    The objective of the study is to evaluate the impact of the written medical information about prematurity delivered at admission to the unit by the doctor, on the state of anxiety of patients hospitalized with a risk of premature delivery.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: Infoprema

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2018
Registry last updated
Jun 16, 2026

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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