Video-Only vs Standard Informed Consent for Amniocentesis or CVS in Pregnant Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares multilingual video-based education with standard verbal informed consent for women offered amniocentesis or chorionic villus sampling. Participants are assigned to four groups by their consent method and the procedure recommended, with measurements of anxiety (STAI-S, STAI-T) and uncertainty (IUS-27) at baseline and after counseling, plus the final decision about undergoing the procedure. The aim is to see if video education improves understanding, lowers anxiety, and influences acceptance rates for invasive prenatal testing. Eligibility includes pregnant women aged 18-45 with singleton pregnancies who are Turkish-speaking and recommended for invasive testing, while excluding those with certain psychiatric histories, prior invasive procedures, or other risk factors. The study is led by Ankara City Hospital Bilkent with no external collaborators and is located in Ankara, Turkey.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Presenting to the Perinatology Unit,
* Aged between 18 and 45 years,
* Having a singleton and live pregnancy,
* Recommended for invasive prenatal diagnostic testing due to medical indications,
* Proficient in reading, writing, and understanding the Turkish language,
* Willing to participate in the study (consenting to informed consent).

Exclusion Criteria:

* Having a history of psychiatric disorders or depression,
* Currently using psychiatric/psychotropic medication,
* Having a history of invasive procedures in previous pregnancies,
* Having a multiple pregnancy,
* Having visual, auditory, or cognitive impairments,
* Leaving more than 3 questions unanswered in the data collection tools (scales and forms) or withdrawing/dropping out of the study before completion.

Where it's running

• Ankara Bilkent City Hospital
  Ankara, Ankara, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: beste taş, md — Ankara Bilkent City Hospital, Department of Obstetrics and Gynecology
• Study coordinator: beste taş, md
• Email: besteklc50@gmail.com
• Phone: 5389797766

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.