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

NCT ID: NCT04229654

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knowledge Expectations Ultrasound

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Pregnant women between 18 and 24.6 weeks

Exclusion Crireria:

* Time constraints
* Lack of interest
* Maternal blindness
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. med Flavio Hernández Castro

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Flavio Hernández-Castro, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Autónoma de Nuevo León

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22066299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31477046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30261776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11070816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12431263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10658849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26039497 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GI15017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.