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

Completed

• Conditions: Preterm Birth

• Registration Number: NCT03646578
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Study First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mesure of the State of anxiety of patients with a risk of premature delivery	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.