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KnowledgeNCT04229654

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

An observational study of Knowledge and Expectations, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Knowledge, Expectations, Ultrasound
What is being tested?
Questionnaire
How many people
400 participants
Where
1 siteMexico
Study dates
4 Nov 2019to 6 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • -Pregnant women between 18 and 24.6 weeks

Who cannot join

  • Time constraints
  • Lack of interest
  • Maternal blindness

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Universitario Dr. José Eleuterio González

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

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

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

Read the 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.

Being tested
Questionnaire
Keywords
knowledge, expectations, anomaly scan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge

    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.

    Measured: 10 minutes

  2. Expectations

    Consisted of 8 items that asked about women´s expectations before the ultrasound examination. A yes/no style were used to measure this outcome.

    Measured: 5 minutes

  3. Perception of the fetus

    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.

    Measured: 5 minutes

Secondary outcomes (1)

  1. Demographic characteristics

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

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start4 Nov 2019
  3. Primary completion6 Jan 2020
  4. Study completion6 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04229654
Sponsor's protocol ID
GI15017
Status last verified
Jan 2020
First submitted
12 Jan 2020
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22066299

  • 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.

    PubMed 31477046

  • 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.

    PubMed 30261776

  • 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.

    PubMed 11070816

  • 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.

    PubMed 12431263

  • 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.

    PubMed 10658849

  • 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.

    PubMed 26039497

Questions about this trial

What is this clinical trial studying?

An observational study of Knowledge and Expectations, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04229654, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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