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

Preterm Birth Clinical Trial

— Infoprema  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646578
• Other study ID #: PI2017_843_0038
• Status: Completed
• Start date: November 1, 2014
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesure of the State of anxiety of patients with a risk of premature delivery	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