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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229654
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez

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.

Condition or disease Intervention/treatment
Knowledge Expectations Ultrasound Other: Questionnaire

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.

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans


Intervention Details:
  • Other: Questionnaire
    A written questionnaire was used to capture demographic data, obstetric history, knowledge, expectations, and perception of anomaly scans.


Primary Outcome Measures :
  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 Outcome Measures :
  1. Demographic characteristics [ Time Frame: 5 minutes ]
    Demographic characteristics were collected, including maternal age, body mass index, education level, marital status, gravidity and parity.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women at 18-24.6 week gestation
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

-Pregnant women between 18 and 24.6 weeks

Exclusion Crireria:

  • Time constraints
  • Lack of interest
  • Maternal blindness

Information from the National Library of Medicine

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


Locations
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Mexico
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Flavio Hernández-Castro, MD PhD Universidad Autónoma de Nuevo León

Publications:

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Responsible Party: Dr. med Flavio Hernández Castro, Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT04229654    
Other Study ID Numbers: GI15017
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez:
knowledge
expectations
anomaly scan
Additional relevant MeSH terms:
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Congenital Abnormalities