Maternal Anxiety Related to How the Pediatrician Provided Prenatal Information About Preterm Birth (Infoprema)
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| ClinicalTrials.gov Identifier: NCT03646578 |
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Recruitment Status :
Completed
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
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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 |
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 |
| 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 |
- 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.
- 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.
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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 |
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.
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
| Principal Investigator: | Pierre Tourneux, MD, PhD | CHU AMIENS |
| Responsible Party: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT03646578 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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maternal anxiety |
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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |