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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03646578
Acronym
Infoprema
Enrollment
65
Registered
2018-08-24
Start date
2014-11-01
Completion date
2017-08-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

maternal anxiety

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).

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.

Interventions

OTHERState 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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mesure of the State of anxiety of patients with a risk of premature delivery3monthsThe 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre Tourneux, PU-PH

CHU AMIENS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026