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

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ClinicalTrials.gov Identifier: NCT03646578
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment
Preterm Birth Other: State of anxiety

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.


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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Maternal Anxiety Related to How the Pediatrician Provided Prenatal Information About Preterm Birth
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety


Intervention Details:
  • Other: 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.



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 hospitalized patients at risk of preterm birth
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646578


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Pierre Tourneux, MD, PhD CHU AMIENS

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03646578     History of Changes
Other Study ID Numbers: PI2017_843_0038
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
maternal anxiety

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications