Awareness, Expectations, and Perception of Anomaly Scan Among Mexican Pregnant Women
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|ClinicalTrials.gov Identifier: NCT04229654|
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment|
|Knowledge Expectations Ultrasound||Other: Questionnaire|
A cross-sectional survey was conducted in two prenatal diagnostic centers located in Monterrey, Nuevo León, México. One was a university prenatal diagnostic center and the other a private one. The centers were purposively selected to represent different characteristics of the level of care and demographic characteristics. The research instrument was a 26-item questionnaire divided into three sections. The first section contained 12 questions designed to assess women's ideas about the purpose and limitations of the scan (yes/no). The second was on expectations before the scan while the third dealt on women´s perception of the fetus during the ultrasound examination. All women attending for a mid-trimester anomaly scan were invited to fill out the first two parts of a pretested structured questionnaire before the scan and after the ultrasound examination, the third part of the questionnaire concerning their experience of the scan session was completed and collected.
Additionally, the questionnaire included demographic questions (age, parity, educational level, marital status). The source of the questionnaire items was interviews with experts.
Ethical approval for this study was obtained from the Institutional review board. The anomaly scan was performed by fetal-maternal specialists between 18 and 24.6-week gestation.
All data were recorded and analyzed using the Statistical Package for the Social Sciences version 22.0 (SPSS Inc, Illinois, USA). Descriptive statistics were used for the sociodemographic data. Categorical variables were compared using the chi-square test or Fisher exact test. Univariate and multivariate regression analyses were performed to delineate the factors associated with a higher knowledge level. A p-value <0.05 was considered statistically significant.
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Awareness, Expectations, and Perception of Anomaly Ultrasound Scan Among Pregnant Women in a Northern México Population|
|Actual Study Start Date :||November 4, 2019|
|Actual Primary Completion Date :||January 6, 2020|
|Actual Study Completion Date :||January 6, 2020|
- Other: Questionnaire
A written questionnaire was used to capture demographic data, obstetric history, knowledge, expectations, and perception of anomaly scans.
- Knowledge [ Time Frame: 10 minutes ]Consisted of 12 items that asked about women´s to evaluate the background knowledge about the purpose and limitations of ultrasound anomaly scan. The first three items asked about the women's knowledge and worries about ultrasound and their understanding of the information provided for their attending physicians. The last 3 items were completed after the ultrasound examination, those items asked about opinions regarding the utility and relief of information provided. The correct answers from the other 6 items were summed to form a total score ranging from 0 to 6. The total scores were categorized into three groups: score 0-2 as poor, 3-4 as intermediate, and 5-6 as good.
- Expectations [ Time Frame: 5 minutes ]Consisted of 8 items that asked about women´s expectations before the ultrasound examination. A yes/no style were used to measure this outcome.
- Perception of the fetus [ Time Frame: 5 minutes ]Consisted of 6 items that asked about women´s perception of the fetus during ultrasound examination. A yes/no style were used to measure this outcome.
- Demographic characteristics [ Time Frame: 5 minutes ]Demographic characteristics were collected, including maternal age, body mass index, education level, marital status, gravidity and parity.
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): NCT04229654
|Hospital Universitario Dr. José Eleuterio González|
|Monterrey, Nuevo León, Mexico, 64460|
|Principal Investigator:||Flavio Hernández-Castro, MD PhD||Universidad Autónoma de Nuevo León|