Clinical trial NCT04229654: Awareness, Expectations, and Perception of Anomaly Scan Among Mexican Pregnant Women
Official title: Awareness, Expectations, and Perception of Anomaly Ultrasound Scan Among Pregnant Women in a Northern México Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knowledge
Expectations
Ultrasound
Keywords: knowledge
expectations
anomaly scan
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consisted of pregnant women of gestational age between 18 and 24.6 weeks. Participants were recruited from two prenatal diagnostic centers located in the northern part of México. The centers were purposively selected to represent different characteristics of the level of care and demographic characteristics.

This study was performed according to the standards of the Helsinki Declaration and approval was obtained from the ethics and educational issues coordinating committee of our University Hospital.

Brief summary: To describe the knowledge, expectations, and perception of women towards the mid-trimester ultrasound scan to detect fetal anomalies in a Mexican population.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

-Pregnant women between 18 and 24.6 weeks

Exclusion Crireria:

* Time constraints
* Lack of interest
* Maternal blindness

Primary outcomes:
measure: Knowledge
timeFrame: 10 minutes
measure: Expectations
timeFrame: 5 minutes
measure: Perception of the fetus
timeFrame: 5 minutes
Secondary outcomes:
measure: Demographic characteristics
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo León
Study officials:
affiliation: Universidad Autónoma de Nuevo León
name: Flavio Hernández-Castro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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