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

NCT ID: NCT03646578

Last Updated: 2018-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-01

Study Completion Date

2017-08-01

Brief Summary

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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

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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.

Conditions

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Preterm Birth

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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State of anxiety

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Tourneux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS

Other Identifiers

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PI2017_843_0038

Identifier Type: -

Identifier Source: org_study_id

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