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

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229654
• Other study ID #: GI15017
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: January 2020
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-Pregnant women between 18 and 24.6 weeks

Exclusion Crireria:

• Time constraints

• Lack of interest

• Maternal blindness

Related Conditions & MeSH terms

• Congenital Abnormalities
• Expectations
• Knowledge
• Ultrasound

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. José Eleuterio González	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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. Review. — View Citation

Buyukbayrak EE, Soysal S, Anik Ilhan G, Yavuzer O. What do expectant parents know about antenatal ultrasound screening? J Matern Fetal Neonatal Med. 2018 Nov 4:1-7. doi: 10.1080/14767058.2018.1530209. [Epub ahead of print] — View Citation

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. Review. — View Citation

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. — View Citation

Tautz S, Jahn A, Molokomme I, Görgen 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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Primary	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.	5 minutes
Primary	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.	5 minutes
Secondary	Demographic characteristics	Demographic characteristics were collected, including maternal age, body mass index, education level, marital status, gravidity and parity.	5 minutes