Clinical trial NCT03825978: Efficacy of Counseling for Prenatal Screening and Diagnostic Tests on Pregnant Women: Randomised Controlled Study
Official title: Evaluation of Efficacy of Counseling for Prenatal Screening and Diagnostic Tests on Pregnant Women's Decisional Conflict, Being Sure of the Decision, Anxiety Levels and Attitudes Towards the Tests: A Randomised Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Chromosome Abnormality
Anxiety
Knowledge, Attitudes, Practice
Keywords: prenatal genetic screening
prenatal diagnosis
counseling
decision
anxiety
nursing
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 260
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to evaluate the effect of counseling for prenatal screening and diagnostic tests on pregnant women's decisional conflict, being sure of the decision, anxiety levels, and attitudes towards the tests. This prospective randomized controlled intervention study was conducted between the dates June 2017 and March 2018 in a training and research hospital, department of obstetrics and gynecology. The sample of the study consisted of 210 pregnant women who took antenatal care between the 8-11th gestational weeks of whom 112 were in the intervention group and 98 were in the control group. The data were collected by using Data Collection Form, The State-Trait Anxiety Inventory (STAI I-II), Decisional Conflict Scale (DCS), Sure Scale (SURE), Knowledge Evaluation Form about Prenatal Genetic Screening and Diagnostic Tests, Prenatal Counseling Satisfaction Form, Decision Satisfaction Form and Attitudes towards the tests Scale. The study carried out in two stages. In the first stage; women's data were collected before and after participating prenatal genetic screening tests. After the results of the screening test were taken, the data were collected again. Counseling was provided for 112 pregnant women about prenatal screening and diagnostic tests before participating tests. Routine clinical information was given for 98 pregnant women who were in control group. Both groups were pre and post-tested at the same times. In the second phase, pregnant women who had diagnostic tests were evaluated. Counseling for prenatal genetic diagnosis tests was provided for 31 pregnant women in inetervetion group women and routine clinical information was providen for 26 pregnant women who were in control group. Data were collected again with data collection tools before and after the diagnostic test.

Detailed description: Pregnant Women Who Had Only Prenatal Genetic Screening Tests In intervention group, pregnant women, who were in 8-11th gestational weeks, before prenatal genetic counseling, answered the questions in "Descriptive Features Data Collection Form", "Decisional Conflict Scale", "The State-Trait Anxiety Inventory scale", "Information Evaluation Form about Prenatal Screening Tests ","Decision Satisfaction Scale", "Attitudes towards the tests Scale". Later, individual interviews were made with pregnant women education was given with slide show about prenatal diagnosis and screening tests to pregnant women. In addition a training brochure which was prepared by the researcher was given to the pregnant women. It took about 20 minutes for the data collection forms to be answered and counseling was took about 25 minutes. After counseling, pregnant women were interviewed again at 14th week. The pregnant women were asked whether they had a screening test and the results were recorded. Then pregnant women were answered "Decisional Conflict Scale", "The State-Trait Anxiety Inventory scale", "Information Evaluation Form about Prenatal Screening Tests ","Decision Satisfaction Scale", "Attitudes towards the tests Scale" again. At the following antenatal visits (16-20th weeks), the pregnant women were asked whether they had triple, quadruple or NIPT and the test results were recorded in the data collection form. At the end of the 20th week, the data collection process of pregnant women who did not have any problems related to fetus and who were recommended to continue routine follow-up was terminated. In control group pregnant women answered same data collection forms in same weeks, but counseling was not given to this group. For this group routine clinical procedure was performed.

Pregnant Women Who Had Also Prenatal Genetic Diagnostic Tests Prenatal genetic diagnostic tests were recommended to pregnant women who had high risk results according to prenatal screening test. Pregnant women with high risk and diagnostic test were referred to genetic consultation in both intervention and control groups. After genetic consultation, pregnant women were answered "Decisional Conflict Scale", "The State-Trait Anxiety Inventory scale", "Information Evaluation Form about Prenatal Diagnostic Tests", "Decision Satisfaction Scale", "Attitudes towards the tests Scale". Then specific counseling was given to invasive test recommended by the doctor. The pregnant woman was asked if she would like to have a diagnostic test and if she didn't want to, the reason was recorded in the data collection form.

If the pregnant woman decided to have a diagnostic test, "The State-Trait Anxiety Inventory scale" was applied again after the procedure. Then pregnant women were interviewed again after about three weeks and their results were evaluated and they answered "Decisional Conflict Scale", "Information Evaluation Form about Prenatal Diagnostic Tests", "Decision Satisfaction Scale", "Attitudes towards the tests Scale". Their decision about to continue or terminate pregnancy was recorded in the data collection form. In control group pregnant women answered same data collection forms in same weeks, but counseling was not given to this group. For this group routine clinical procedure was performed.

Eligibility criteria: Inclusion Criteria:

* taking first antenatal follow-up in 8-11. gestational weeks in where the study is conducted to have a single pregnancy
* to continue take the antenatal care in the hospital where the research was conducted
* at least primary school graduation,
* voluntary to participate the research.

Exclusion Criteria:

* want to exit from the study at her own request
* continue to antenatal follow-up in another hospital.

Primary outcomes:
measure: Anxiety
timeFrame: In 8-11th gestational weeks
measure: Decisional Conflict
timeFrame: In 8-11th gestational weeks
measure: SURE Scale
timeFrame: In 8-11th gestational weeks
measure: Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests
timeFrame: In 8-11th gestational weeks
measure: Attitudes Towards The Tests Scale
timeFrame: In 8-11th gestational weeks
measure: Decision Satisfaction Form
timeFrame: In 8-11th gestational weeks
Secondary outcomes:
measure: Anxiety
timeFrame: In 13-14th gestational weeks
measure: Decisional Conflict Scale
timeFrame: In 13-14th gestational weeks
measure: SURE Scale
timeFrame: In 13-14th gestational weeks
measure: Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests
timeFrame: In 13-14th gestational weeks
measure: Attitudes Towards The Tests Scale
timeFrame: In 13-14th gestational weeks
measure: Decision Satisfaction Form
timeFrame: In 13-14th gestational weeks
Other outcomes:
measure: Decisional Conflict Scale
timeFrame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
measure: SURE Scale
timeFrame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
measure: Knowledge Form About Prenatal Genetic Diagnostic Tests
timeFrame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
measure: Attitudes Towards The Tests Scale
timeFrame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
measure: Decision Satisfaction Form
timeFrame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
measure: Anxiety
timeFrame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
measure: Anxiety
timeFrame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
measure: Decisional Conflict Scale
timeFrame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
measure: SURE Scale
timeFrame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
measure: Knowledge Form About Prenatal Genetic Diagnostic Tests
timeFrame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
measure: Attitudes Towards The Tests Scale
timeFrame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
measure: Decision Satisfaction Form
timeFrame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
Locations:
city: Ankara
country: Turkey
facility: Health Science University
city: Ankara
country: Turkey
facility: University Of Health Sciences
Study officials:
affiliation: Health Science University
name: İlknur Yeşilçınar, PhD. RN.
role: STUDY_DIRECTOR
affiliation: Health Science University
name: Gülten Güvenç, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Martin L, Gitsels-van der Wal JT, de Boer MA, Vanstone M, Henneman L. Introduction of non-invasive prenatal testing as a first-tier aneuploidy screening test: A survey among Dutch midwives about their role as counsellors. Midwifery. 2018 Jan;56:1-8. doi: 10.1016/j.midw.2017.09.008. Epub 2017 Sep 24.
citation: Amel S.H., Ali A, Hassan S.A, Momtaz M., Abdelhaleem Z., Negm S. Impact of A Structured Prenatal Counseling on Anxiety Level Among Women Undergoing Amniocentesis. American Journal of Research Communication, 2014; 2(6): 97-108} www.usa-journals.com, ISSN: 2325-4076.
citation: Long S, O'Leary P, Lobo R, Dickinson JE. Women's Understanding and Attitudes towards Down Syndrome and Other Genetic Conditions in the Context of Prenatal Screening. J Genet Couns. 2018 Jun;27(3):647-655. doi: 10.1007/s10897-017-0167-7. Epub 2017 Oct 24.