- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04229654
Awareness, Expectations, and Perception of Anomaly Scan Among Mexican Pregnant Women
Awareness, Expectations, and Perception of Anomaly Ultrasound Scan Among Pregnant Women in a Northern México Population
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario Dr. José Eleuterio González
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
-Pregnant women between 18 and 24.6 weeks
Exclusion Crireria:
- Time constraints
- Lack of interest
- Maternal blindness
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 minutes
|
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.
|
5 minutes
|
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.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic characteristics
Time Frame: 5 minutes
|
Demographic characteristics were collected, including maternal age, body mass index, education level, marital status, gravidity and parity.
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5 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Flavio Hernández-Castro, MD PhD, Universidad Autonoma de Nuevo Leon
Publications and helpful links
General Publications
- Ugwu AC, Udoh BE, Eze JC, Eze PC. Awareness of information, expectations and experiences among women for obstetric sonography in a south east Nigeria population. East Afr J Public Health. 2011 Jun;8(2):132-4.
- Westerneng M, Diepeveen M, Witteveen AB, Westerman MJ, van der Horst HE, van Baar AL, de Jonge A. Experiences of pregnant women with a third trimester routine ultrasound - a qualitative study. BMC Pregnancy Childbirth. 2019 Sep 2;19(1):319. doi: 10.1186/s12884-019-2470-9.
- Buyukbayrak EE, Soysal S, Anik Ilhan G, Yavuzer O. What do expectant parents know about antenatal ultrasound screening? J Matern Fetal Neonatal Med. 2020 Jun;33(11):1811-1817. doi: 10.1080/14767058.2018.1530209. Epub 2018 Nov 4.
- Bricker L, Garcia J, Henderson J, Mugford M, Neilson J, Roberts T, Martin MA. Ultrasound screening in pregnancy: a systematic review of the clinical effectiveness, cost-effectiveness and women's views. Health Technol Assess. 2000;4(16):i-vi, 1-193. No abstract available.
- Garcia J, Bricker L, Henderson J, Martin MA, Mugford M, Nielson J, Roberts T. Women's views of pregnancy ultrasound: a systematic review. Birth. 2002 Dec;29(4):225-50. doi: 10.1046/j.1523-536x.2002.00198.x.
- Tautz S, Jahn A, Molokomme I, Gorgen R. Between fear and relief: how rural pregnant women experience foetal ultrasound in a Botswana district hospital. Soc Sci Med. 2000 Mar;50(5):689-701. doi: 10.1016/s0277-9536(99)00321-4.
- Salmoukas C, Kundu S, Soergel P, Hillemanns P, von Kaisenberg C, Staboulidou I. Background Knowledge and Attitude of Pregnant Women towards Ultrasound Screening at 20-23 Weeks Gestation. Z Geburtshilfe Neonatol. 2016 Feb;220(1):16-20. doi: 10.1055/s-0035-1545287. Epub 2015 Jun 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GI15017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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