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

NCT03646578 | Completed

• 1 other identifier: PI2017_843_0038
• Study Type: observational
• Target: 65
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Preterm Birth

Keywords

maternal anxiety

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

State of anxiety OTHER

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 hospitalized patients at risk of preterm birth

You may qualify if:

• patients hospitalized in the service of pregnancies and having a risk of premature delivery.
• Term \<34 SA

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Pierre Tourneux, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 24, 2018
• Study Start: November 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share