ClinicalTrials.Veeva

Menu

Efficacy of Counseling for Prenatal Screening and Diagnostic Tests on Pregnant Women: Randomised Controlled Study

S

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Status

Completed

Conditions

Chromosome Abnormality
Decision Making
Knowledge, Attitudes, Practice
Anxiety

Treatments

Behavioral: Prenatal Genetic Counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT03825978
Ilknur Yesilcinar

Details and patient eligibility

About

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.

Full 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.

Enrollment

260 patients

Sex

Female

Ages

19 to 46 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

260 participants in 2 patient groups

Intervention
Active Comparator group
Description:
An individual and comprehensive prenatal genetic counseling was given to all pregnant women in the intervention group, including all screening tests and diagnostic tests for prenatal diagnosis and screening tests at the first antenatal visit.
Treatment:
Behavioral: Prenatal Genetic Counseling
Control
No Intervention group
Description:
There was no intervention from the first antenatal visit in the control group. Routine clinical information was given about prenatal screening and diagnostic tests.

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems