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OpenTrials
Completed

NCT Number: NCT04229654

Awareness, Expectations, and Perception of Anomaly Scan Among Mexican Pregnant Women

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

Completed

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Pregnant women between 18 and 24.6 weeks

Exclusion Crireria:

  • Time constraints
  • Lack of interest
  • Maternal blindness

Treatment and study plan

Questionnaire

Other

A written questionnaire was used to capture demographic data, obstetric history, knowledge, expectations, and perception of anomaly scans.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Demographic characteristics

    Time frame: 5 minutes

    Demographic characteristics were collected, including maternal age, body mass index, education level, marital status, gravidity and parity.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

Awareness, Expectations, and Perception of Anomaly Ultrasound Scan Among Pregnant Women in a Northern México Population

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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