Viewing Study NCT00341822



Ignite Creation Date: 2024-05-05 @ 4:55 PM
Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00341822
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2006-06-19

Brief Title: Invasive Prenatal Testing Decisions in Pregnancy After Infertility
Sponsor: National Human Genome Research Institute NHGRI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Prenatal Testing Decisions in Pregnancy After Infertility
Status: COMPLETED
Status Verified Date: 2007-12-28
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will explore the decision-making experiences of women who are currently pregnant following a period of infertility on whether or not to undergo an invasive prenatal test IPT procedure such as amniocentesis or chorionic villus sampling Women who become pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy When choosing whether or not to have IPT they are faced with a complex decision set in the unique context of a pregnancy that they often perceive as exceptionally precarious

Women who are pregnant with their first child after a period of infertility and have made a decision regarding whether or not to undergo IPT may be eligible for this study

Participants complete an online password-protected questionnaire that measures infertility and decision-making variables and explores womens perceptions of the impact of infertility on their IPT decision-making process The questionnaire covers the following areas

Subjects demographic information such as age marital status number of children education race ethnicity
Subjects infertility history
Subjects thoughts and feelings about infertility
Subjects thoughts and concerns about other peoples eg husband doctor other infertile women opinions about IPT
Subjects decision about whether or not to have IPT and her feelings regarding the decision
The effect of subjects infertility history on her decision to have or not have IPT
Detailed Description: Women who are pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy When choosing whether or not to have invasive prenatal testing they are faced with a complex decision set in the unique context of a pregnancy that they often perceive as exceptionally precious The proposed study aims to explore the invasive prenatal testing decision-making experiences of women who are pregnant after infertility A cross-sectional design will be used to investigate relationships between the infertility experience and decisional conflict associated with deciding whether or not to have invasive prenatal testing Women who are pregnant after infertility will be recruited from online support groups and websites for pregnancy after infertility Participants will be asked to complete a questionnaire that measures infertility and decision-making variables and elicits their perceptions of the impact of infertility on their IPT decision-making experience The main outcome measure is decisional conflict

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
06-HG-N132 None None None