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

August 23, 2018 updated by: Centre Hospitalier Universitaire, Amiens

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

65

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

60 hospitalized patients at risk of preterm birth

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2017_843_0038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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